1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country?

In Thailand, drugs, biologics, and medical devices are regulated by the Thai Food and Drug Administration (Thai FDA), under the supervision of the Ministry of Public Health (MOPH).

More precisely, the Drug Division of the Thai FDA is the main regulatory body controlling pre-marketing and post-marketing of Drugs and Biologics in the Kingdom; while the Medical Device Control Division of the Thai FDA is the main regulatory body controlling pre-marketing and post-marketing of medical devices in the Kingdom.

 

2. What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices?

The Drug Act, B.E. 2510 (1967), as amended, provides the regulatory framework for the marketing authorization and post-marketing surveillance of drugs and biologics in Thailand. The Medical Device Act, B.E. 2551 (2008), as amended, provides legislation governing the marketing authorization and post-marketing surveillance of medical devices in Thailand. In general, there are no specific regulations related to pricing for drugs and medical devices. The prices of medicinal products are only controlled when they are listed in the National List of Essential Drugs (NLED), a list of medications used by public hospitals and public health services. Under the control of the Ministry of Finance, drugs on the NLED are subject to a median price policy. However, these pricing regulations only apply to drugs that are listed on the NLED and are prescribed in public hospitals. Private hospitals and drug stores are free to set their own prices for the drugs they sell, but the price must not exceed the sticker price—the maximum price set by the distributor.

The cost of drugs and medical devices on the NLED can be reimbursed by the government. Government hospitals generally provide drugs and medical devices from the NLED to civil servants and other persons under the universal coverage (also known as the Baht 30 Scheme). Civil servants and patients under universal coverage are not required to pay anything to the hospital. Public hospitals will be reimbursed in full by the government for the cost of the drugs and medical devices used in these cases. Another reimbursement scheme available to Thais is the Social Security Scheme, which is available to employees of private companies. For more information on reimbursements, please see the answer to question 10 below.

 

Classification of Pharmaceutical Products

Chemical drugs are classified into three categories:

(i)  New Drug

A new drug is a drug formulation that has not been registered in Thailand before. New drugs include products of a new chemical entity (NCE), a new combination, a new dosage form, a new drug delivery system, a new indication, a new strength, or a new route of administration.

 

(ii) New Generic Drug

A new generic drug is a drug formulation that has the same active pharmaceutical ingredient(s), dosage form, indication(s), route of administration, and strength as a reference drug that had previously been approved by the Thai FDA after B.E. 2534 (1991).

 

(iii) Generic Drugs

A generic drug is a drug formulation that has the same active pharmaceutical ingredient(s), dosage form, indication(s), route of administration, and strength as a reference drug that had previously been approved by the Thai FDA before B.E. 2534 (1991).

 

Classification of Medical Devices

On February 15, 2021, the risk classification system, as laid out in the ASEAN Medical Device Directive (AMDD), entered into force resulting in significant changes in the classification system and registration scheme of medical devices in Thailand. Under the Medical Device Act, medical devices are classified into three categories, depending on the level of risk of the medical device to individuals and the general public:

 

(i) Licensed Medical Devices (equivalent to Class 4 Medical Device)

The Licensed Medical Device category is the most strictly controlled class. Prior to importation and production, the applicant must apply for and obtain a license for importation or manufacturing of licensed medical device (or product license). The license for importation or manufacturing of a licensed medical device remains valid for five years and it is renewable. The full Common Submission Dossier Template (CSDT) is required.

Examples of Licensed Medical Devices include SARS-CoV-2 diagnostic test kits, HIV diagnostic test kits (but not HIV self-test kits), methamphetamine test kits, Hyaluronic acid-based filler for correction of skin depressions, silicone breast implants, blood bags, etc.

 

(ii) Detailed Notification Medical Devices (equivalent to Class 2 and Class 3 Medical Device)

Detailed Notification Medical Devices are subject to a less intensive review procedure than Licensed Medical Devices. Prior to importation and production, the applicant must submit a dossier and obtain an approval certificate for importation or manufacturing of a Detailed Notification Medical Device (or product license). The certificate for importation or manufacturing of a Detailed Notification Medical Device remains valid for five years and is renewable. The full Common Submission Dossier Template (CSDT) is required.

Examples of Detailed Notification Medical Devices include condoms, contact lenses, surgical gloves, rehabilitation devices, HIV self-test kits, etc.

 

(iii) Listed (or General) Medical Device (equivalent to Class 1 Medical Device)

Listed Medical Devices are medical devices that pose a low risk to individuals and the general public. Medical devices under this category are subject to the least stringent control by the Thai FDA. Prior to importation and production, the applicant must submit the dossier and obtain an approval certificate for importation or manufacturing of a listed medical device (or product license). The certificate for importation or manufacturing of a Listed Medical Device remains valid for five years and is renewable. The full Common Submission Dossier Template (CSDT) is NOT required.

Examples of Listed Medical Devices include adhesive bandages, examination gloves, specimen receptacles, powered hospital beds, wheelchairs, ophthalmic lenses with optical power, etc.

 

3. What are the steps to obtain authorization to develop, test, and market a product?

Pharmaceutical Products

Generally, there are three steps to obtaining market authorization. First, an established company in Thailand must obtain either a (domestic) drug manufacturing license or a drug importation license from the Thai FDA. After obtaining one of these licenses, the company can submit a request to manufacture or import samples for various purposes (e.g., clinical trials, research and development, etc.). For research purposes, the clinical trial protocol must be approved by the relevant ethics committee of the applicable investigation site. Once those first two steps are complete, the company can apply for marketing authorization of the particular drug product.

For imported drug products, importers are also required to submit a GMP clearance application for each drug product in order to ensure that the overseas manufacturing site meets GMP standards. The GMP clearance approval granted by the Thai FDA will have the same validity as the GMP certificate issued by the regulatory authority in the country of manufacturing. Since Thailand is a member of PIC/S GMP, the PIC/S GMP Guide is the preferable standard/reference for GMP inspection.

Finally, the drug registration dossier can be submitted to the Thai FDA through the e-submission pathway, applying the eCTD format. The Marketing Authorization (MA) license for drug products is valid for seven years and is renewable.

 

Medical Devices

There are two steps to obtaining market authorization for medical devices. First, an established company in Thailand must obtain either a medical device manufacturing license or a medical device importation license from the Thai FDA. Once that is complete, the company can then apply for a marketing authorization for the particular medical device.

 

4. What are the approximate fees for each authorization?

 

According to the Ministerial Notification: Official Fees for Drug Products published on 1 Dec 2023 and Ministerial Notification: Official Fees for Medical Devices published on 19 Sep 2024, the official fees assessed will not exceed the maximum values provided in the table below. This new fee schedule is designed to facilitate the government for levying fees by defining the actual cost for each type of registration.

Pharmaceutical products

(1)	Modern Drug Manufacturing Licenses	THB 8,500	per license
(2)	Modern Drug Selling Licenses (Retail)	THB 2,500	per license
(3)	Modern Drug Selling Licenses (Wholesale)	THB 2,000	per license
(4)	Modern Drugs Import License	THB 10,500	per license
(5)	Technical Document Evaluation for New Drug Registration	THB 155,000 – 395,000	per product
(6)	Technical Document Evaluation for Generic Drug Registration	THB 39,000 – THB 59,000	per product
Remarks: The fees for Nos. 5-6 do not include (i) application fee, which will be between THB 1,000 – THB 2,500, and (ii) MA license fee, which will be THB 2,000.

 

Medical devices

 

(1)	Medical device manufacturing license	THB 14,100	per license
(2)	Medical device import license	THB 16,100	per license
(3)	Medical device sale license	THB 5,000	per license
(4)	Product license – Imported Listed Medical Device	THB 2,000	per license
(5)	Product license – Imported Detailed Notification Medical Device	THB 10,000	per license
(6)	Product license – Imported Licensed Medical Device	THB 20,000	per license
(7)	Technical Document Evaluation for Licensed and Detailed Medical Device Registration	THB 32,000 -110,000	per product
Remarks: Fee Nos. 4, 5, and 6 do not include application fee which will be between THB 500 – THB 1,000.

5. For how long are marketing authorizations/registrations valid? How are marketing authorizations/registrations renewed?

Pharmaceutical Products

The modern drug manufacturing and modern drug import license are both valid for a period of one year (from January 1 to December 31). Each type of license must be renewed before December 31 each year in order to be carried over to the following year.

According to Amendment No. 6 of the Drug Act, marketing authorization licenses of drug products that received approval after October 13, 2019, will have a validity of seven years, and are renewable.

 

Medical Devices

The medical device manufacturing and medical device importing license are both valid for a period of five calendar years. Each type of license must be renewed before December 31 of the fifth year.

The medical device selling license is valid for a period of one calendar year (from January 1 to December 31) and must be renewed before December 31 each year.

According to the Medical Device Act, as amended, the product licenses of medical devices (Listed Medical Devices, Licensed Medical Devices and Detailed Notification Medical Devices) are valid for a period of five years, and are renewable.

 

6. Are there any differences for local manufacturers versus foreign-owned manufacturers? How does the authorization process differ between original products and generic products?

There are no significant differences between local and foreign-owned manufacturers. Both types of companies are required to apply for marketing authorization licenses.

There are, however, major differences between original and generic product registration. Original drugs (or patented drugs) are classified as new drugs, meaning the registration dossier must include both non-clinical and clinical documentation. To register an oral-solid dosage form (i.e., tablet or capsule) generic product which is oral-solid dosage forms i.e., tablet, capsule, companies can merely submit the bioequivalence study to prove pharmaceutical equivalence with the original product.

Further, after obtaining a market authorization license, new drugs (original products) must undergo a mandatory Safety Monitoring Program (SMP). During the SMP, new drugs can only be dispensed in hospitals. The company manufacturing the original drug must provide periodic safety updates to the Thai FDA for the first two years. After the committee evaluates these reports over the two-year period, the drug can be released from the SMP and re-classified. Some new generic drugs may be subject to the SMP requirement if the original product has not been yet released from the SMP or the generic drug is considered a highly ethical drug (e.g., anticancer drug).

 

7. How are combination products (drug + drug, drug + biologic, drug + device, biologic + device, drug + biologic + device) regulated?

If the drug combination is new, the Thai FDA will classify it as a new drug.

For a combination between a drug and medical device, the classification will be based on the products intended use; therefore, it requires an evaluation by both the Drug Division and the Medical Device Control Division. However, the final classification decision will be at the Thai FDA’s discretion.

For example, drugs available in prefilled syringes are classified as drugs. However, if the main function of the combination acts like a medical device, such combination will be classified as a medical device (i.e., drug eluting stent, condom with spermicide, Heparin-coated catheters, etc.)

Combination products that fall within the scope of medical devices are classified as Licensed Medical Devices − the highest risk (class 4), which must obtain a license prior to import or manufacture the product.

 

8. How is compliance with regulation monitored and evaluated? Is the regulatory regime comparable with the U.S. Food and Drug Administration or the European Medicines Agency expectations and requirements?

Thailand’s regulatory regime is comparable to that in the U.S. because it is governed by a centralized process through the Thai FDA, and specific subdivisions of the Thai FDA, namely the Drug Division and the Medical Device Control Division, are responsible for supervising drugs and medical devices, respectively.

In order to comply with the Thailand’s regulatory regime, pharmaceutical companies must follow the provisions laid out in the Drug Act, as amended, and medical device companies must follow the provisions laid out in the Medical Device Act, as amended.

In order to monitor pharmaceutical and medical device companies and ensure that there are no adverse effects regarding the safety or efficacy of drugs, the Thai FDA conducts consistent pre- and post-marketing inspections. These inspections can come in a variety of forms, including on-site inspections for GMP compliance, on-site inspections to explore any aspect of the manufacturing process, and general on-site visits on a yearly basis.

 

9. What is the potential range of penalties for noncompliance?

Under the Drug Act and the Medical Device Act, penalties for noncompliance by a licensee include suspension of import licenses, revocation of the marketing authorization licenses, a financial penalty, and imprisonment.

 

 

10. Is there a national healthcare system? If so, how is it administered and funded?

The national healthcare system is divided into three main schemes:

1. The Social Security Scheme (SSS): This scheme is administered by the Social Security Office and financed by tripartite contributions from the government, employers, and employees. It covers employees, and employers with one or more employees. This scheme is not applicable to those covered by the Civil Servant Medical Benefit Scheme (below) or to employees of foreign entities.
2. The Civil Servant Medical Benefit Scheme (CSMBS): This scheme is administered by the Social Security Office and provides health care benefits to government officials and their dependents (spouse, parents, and up to three children).
3. The Universal Health Coverage Scheme (UCS): This scheme is administered by the MOPH and covers the remaining population not covered under either the SSS or the CSMBS.

 

11. How does the government (or public) healthcare system function with private sector healthcare?

In general, private sector healthcare companies are not subsidized by the government. However, some private sector healthcare companies may be partially subsidized by the government if they cooperate with the UCS or SSS. Subsequently, these private hospitals are able to provide healthcare services for patients who are registered at their hospital under the UCS or SSS.

 

12. Are prices of drugs and devices regulated and, if so, how?
    

The prices of medicinal products are only controlled when they are listed in the National List of Essential Drugs (NLED), a list of medications used by public hospitals and public health services. Under the control of the Ministry of Finance, drugs on the NLED are subject to a median price policy. However, these pricing regulations only apply to drugs that are listed on the NLED and are prescribed in public hospitals. Information about median pricing can be found on (http://ndi.fda.moph.go.th/drug_value). Private hospitals and drug stores are free to set their own prices, but the price must not exceed the sticker price—the maximum price set by the distributor.

In May 2019, the Department of Internal Trade issued Notification No. 52 on the Price Reporting of Drugs, Devices, and Healthcare Services, which requires distributors to report the price of drugs sold to private hospitals. Further the private hospitals must also report the selling price of medicinal products and medical devices they purchase

 

13. How are drugs and devices used by patients paid for? What roles do public and private payers play?

 

Reimbursement of drugs and devices is only available for those listed on the NLED, and prescribed at public hospitals (or private hospitals that cooperate with the UCS or SSS). Therefore, the government will ultimately bear the cost of NLED-listed drugs and devices at all public hospitals and a select number of private hospitals. For all other drugs and devices, including those prescribed by private hospitals that do not cooperate with either the UCS or SSS, the patient will be solely responsible for the total cost.

 

14. Who dispenses drugs and devices to patients and how are those dispensers compensated?

Licensed practitioners, such as doctors and dentists, are authorized to prescribe drugs and medical devices to patients. Following prescription from a licensed practitioner, a licensed pharmacist will dispense the prescribed drugs or medical devices to patients. Drugs and medical devices are dispensed by pharmacy departments in hospitals. In 2024, the National Health Security Office (NHSO), which is the regulatory authority that regulates reimbursement under the UCS, allowed pharmacies to dispense drugs for treatment of 32 minor illnesses for patients under the UCS. Participating pharmacies must display the “30 Baht Treatment Anywhere” logo in front of the store, and pharmacists can now provide free consultations and medications covering these minor illnesses, such as headaches, diarrhoea, colds, etc. Pharmacies registered under this program will receive THB 180 reimbursement per case. The drugs to be dispensed are listed in the NLED.

 

15. What are the professional and legal responsibilities of those who dispense drugs and devices? What role do they play in providing patient care, information, and safety?

Only licensed practitioners such as doctors and dentists are authorized to prescribe drugs in Thailand, after which such drugs will be dispensed by a licensed pharmacist. Generally, most drugs are available at the hospital and at pharmacies. Unlike for drugs, there are no dispensing requirements for medical devices.

Only doctors holding a medical license from the Medical Council of Thailand can practice the medical profession in Thailand, which includes the diagnosing, treating, and preventing diseases. Likewise, only pharmacists holding a pharmacy license from the Pharmacy Council of Thailand can dispense drugs to patients.

Medical professionals who work in hospitals may have additional responsibilities such as investigating a patient’s drug allergies, and monitoring drug levels.

 

Also from this Legal Handbook

1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?

No, the clinical trial does not need to be conducted locally in order to obtain marketing approval. The Thai FDA only requests that clinical data be arranged in either the format of Part 4 of the ASEAN Common Technical Dossier (ACTD) or Module 5 of the ICH CTD.

 

2. How are clinical trials funded?

Clinical trials are funded by sponsors or initiated by the investigators themselves (i.e., drug companies, universities, registered charitable organizations, hospital funds).

 

3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?

The Thai FDA will review and approve clinical trial protocols when they receive an application for conducting a clinical trial to support drug registration. The requirements for conducting clinical trials are as follows:

1. The applicant must first obtain ethics approval to conduct a clinical trial on humans from the Ethical Review Committee for Research in Human Subjects of the MOPH (ERC) and/or the ethics committee of the hospital, research institute or university that will conduct the trial. If approval is obtained from the ethics committee of the facility conducting the trial, approval from the ERC is usually optional.
2. The applicant must ensure that the protocols of the trial comply with the guidelines for Good Clinical Practice (ICH/GCP) and Good Laboratory practice (ICH/GLP). The complete version of the trial protocols must be submitted to both the Thai FDA and the relevant ethics committee.
3. The applicant must submit the package insert or summary of product characteristics, safety report, and progression report to the Thai FDA or the ethics committee. (if required).

 

1. What are the requirements for consent by participants in clinical trials?

Currently, there is no specific standalone legislation governing clinical trials in Thailand.

Nonetheless, consent is indirectly regulated by the Civil and Commercial Code, the National Health Act, B.E. 2550 (2007), the Mental Health Act, B.E. 2551 (2008), and the Personal Data Protection Act B.E. 2562 (2019).

As a typical practice of the GCP, trial subjects are required to sign an informed consent form before commencement of a clinical trial. The consent form must (1) provide information on how the data will be used, and (2) emphasize that participation is voluntary, meaning subjects have the right to withdraw from the trial at any time. A consent form must be signed and dated by the volunteer. In the event that a patient or volunteer cannot give consent on their own, consent can be provided on their behalf by their legal representative.

 

5. May participants in clinical trials be compensated?

Yes. Also, participants in clinical trials may be indemnified for any injuries or loss that may occur as a result of the clinical trial.

 

6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?

The sponsor of the clinical trial is held solely responsible for any injury or loss that may occur as a result of the study; not part of the responsibility is absorbed by the other partners or institutions performing the research. Although insurance is not always a mandatory requirement, the relevant ethics committee will always ask whether insurance is available for volunteers in the clinical trial.

Also from this Legal Handbook

1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products?

Pharmaceutical Products

The authorization processes for the marketing of new drugs, biologics, over-the-counter medications, and other medicinal products are the same.

Companies and individuals that wish to place a drug on the market must:

• Obtain a license from the Thai FDA to manufacture, sell or import drugs. Both the drug manufacturing license and the drug import license are valid from January 1 to December 31, and must be renewed on a yearly basis.
• After obtaining a license, the manufacturer or importer must submit an application for manufacturing or importing drug samples. For imported drug products, an importer will also be required to submit an application for GMP clearance of the overseas manufacturer in order to ensure that the overseas manufacturing site meets PIC/S GMP requirements. The GMP Clearance approval granted by the Thai FDA will have the same validity as the GMP certificate issued by the regulatory authority in the country of manufacturing.
• Submit a full marketing approval application, including samples, to the Thai FDA for review and registration. The registration scheme and technical documentation vary depending on the classification of the drug product. Currently, the drug registration dossier can be arranged in either the ASEAN Common Technical Dossier (ACTD) or the ICH-eCTD format. The timeframe for registration approval for a new drug is approximately 220 business days. For a generic drug, the timeframe for registration approval is approximately 155 business days.

 

Medical Devices

Companies and individuals that wish to place a medical device on the market must:

• Obtain a license from the Thai FDA to manufacture or import medical devices. The medical device manufacturing license and the medical device importing license are both valid for a period of five years. Each type of license must be renewed before December 31 of the fifth year.
• Submit a full marketing approval application to the Thai FDA for review and registration. The registration dossier template for Licensed Medical Devices and Detailed Notification Medical Devices must comply with the format of the Common Submission Dossier Template (CSDT), as outlined in AMDD. The timeframe for registration approval of Licensed Medical Devices and Detailed Notification Medical Devices is around 200–300 business days. As for Listed Medical Devices, the Thai FDA grants automatic approval for medical devices that have not been regulated under certain notifications

 

2. What is the authorization process for the marketing of generic versions of these products?

The authorization process for the marketing of generic products is the same as the process for new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products. For more information, please see question 3.1 (above).

The Drug Act, as amended, is the main act regulating marketing authorization for modern drugs, including biologics and other medicinal products.

Registration of new modern drugs requires the applicant to submit a complete ASEAN Common Technical Dossier (ACTD) or ICH Common Technical Dossier (ICH CTD)—which includes a quality study, non-clinical study, and clinical study—together with product samples, to the Thai FDA. If the application passes the review stage, the new modern drug will undergo a two-year safety monitoring period.

The requirements for registering generics are similar to those for registration of new modern drugs; however, the documents required in the ACTD slightly differ. For generic products, the Thai FDA only requires that a quality study and bioequivalent study accompany the ACTD.

 

3. What are the typical fees for marketing approval?

Please see question 1.4 (above).

 

4. What is the period of authorization and the renewal process?

Please see question 1.5 and 3.1 (above).

 

Renewal of Drug MA License

The procedure for renewal of drug MA licenses is prescribed in the following bylaws of the Drug Act:

• MOPH Regulation 2023 Re: Renewal of Drug Registration License (or MA license)
• MOPH Notification Re: Prescribing the Application Form for Renewal of MA License

According to these bylaws, an MA license holder who wishes to renew a drug registration license must file a renewal application with the Thai FDA within 180 days of the drug registration license expiring, together with the necessary supporting documents.

 

5. What are the requirements, if any, for post-approval pharmacovigilance?

All new drugs registered and approved for marketing in Thailand must undergo a mandatory SMP for at least two years. During the SMP, new drugs can only be dispensed in hospitals. The company must provide periodic safety updates and report any adverse reactions to the Thai FDA during this time period.

Even though SMPs are not an obligation for generic products or medical devices, the Thai FDA still requires manufacturer of these products to submit adverse effect reports. This report must include the total number of products dispensed, the total number of patients exposed, and the number and details of adverse drug reactions (ADR).

The Thailand Health Product Vigilance Centre (HPVC), under the supervision of the Thai FDA, is the main organization responsible for collecting and monitoring information about adverse events and corrective action of health products (including drugs and medical devices). There are several channels for submitting a report including by mail, in person, online, via email (adr@fda.moph.go.th), or via facsimile (66+ 2591 8457).

 

6. Are foreign marketing authorizations recognized?

Pharmaceutical Product

Applicants do not receive a relaxed or expedited review process because of any foreign marketing authorizations. However, the application form requires applicants to inform the Thai FDA of any approved or pending market authorizations granted in other countries. If foreign market authorizations have been obtained in a country where the regulatory practice is credible and globally accepted, such authorization could be used as evidence to support the application.

In some cases, the drug registration could be carried out via the Abridged Evaluation Pathway. To fall within the scope of the Abridged Evaluation Pathway, the applicant should ensure that the following criteria are met:

• The MA drug registration dossier is submitted to the Thai FDA within two years from the date of approval of the drug by the benchmark agency (e.g., EMA, US FDA, TGA, Health Canada, MHRA, PMDA). If there is a need to submit the application after such date, the applicant must consult with the Thai FDA on a case-by-case basis. In any case, the maximum period for submission is three years from the date the benchmark agency approved the drug.
• The MA license approved by the benchmark agency as well as the indications, dosage strength, treatment regimen, and patient population must not be revoked, rejected, or withdrawn, nor can the evaluation or approval be suspended during an appeal of the benchmark agency’s decision.

 

Furthermore, the applicant can request a Priority Review, if a drug product is intended for preventing and/or treating:

• Diseases considered as immediate health problems in Thailand with urgent need (e.g., infectious diseases);
• Serious life-threatening conditions (e.g., AIDS treatment drugs, anti-cancer drugs, etc.); or
• Other drugs deemed appropriate by the Thai FDA.

 

There is no difference in registration requirements under the Abridged Evaluation Pathway and priority review; however, the timeframe for evaluation of a drug registration dossier will be reduced from the normal registration process. For example, the timeframe for the normal registration pathway of a new drug (i.e., a new chemical entity) is 220 business days. With the Abridged Evaluation Pathway, the timeframe will be reduced to 180 business days. In cases where the priority review is applicable, the timeframe will be further reduced to 150 business days.

 

Medical Devices

The Thai FDA has provided special registration schemes, which could expedite the registration process of a detailed notification medical device or a licensed medical device that has already been approved in certain countries.

(1) Thailand FDA – HSA Singapore Regulatory Reliance Scheme

The Thailand FDA – HSA Singapore Regulatory Reliance Scheme is a registration pathway that could shorten the registration of Detailed Notification Medical Devices (Classes 2, 3) and Licensed Medical Devices (Class 4) that have already been approved in Singapore. The Medical Device Control Division of the Thai FDA has recognized the Singapore Health Science Authority Agency as a reference agency. Under this scheme, the Thai FDA will review the evaluation report of a medical device issued by the HSA. The average review time is 60 business days. Note that medical devices registered under this scheme must have the same indications/intended use as approved by HSA Singapore.

 

(2) Concise Evaluation Scheme

The Concise Evaluation Scheme is available for both Detailed Notification Medical Devices and Licensed Medical Devices that have already been approved in the “big five” countries (i.e., the US, the EU, Canada, Australia and Japan). Under this scheme, the expert review process is waived. The registration dossier is evaluated by the Thai FDA official, and the registration timeline will be reduced to six months. Medical devices registered under this scheme must have the same indications/intended use as approved by the reference countries.

To participate in the Concise Evaluation Scheme, the medical device must either:

• Have been registered in one of the “big five” countries for more than three years; or
• Have been registered in two of the “big five” countries for more than one year.

 

7. Are parallel imports of medicines or devices allowed?

Parallel imports are not prohibited as long as the importer has obtained a drug import license and marketing authorization for each of the pharmaceutical products before importing such products into Thailand. In practice, there is a technical barrier, as the registration of pharmaceutical products and medical devices requires a technical dossier from the overseas product owner.

 

8. What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners?

Pharmaceutical companies must ensure that their marketing activities are in accordance with Drug Act and the Code of Conduct of Pharmaceutical Industry.

In general, a state official can only receive property or any other benefit from any person (other than a relative) if the value of the benefit received from each person, and on each occasion, is less than THB 3,000.

In order to prevent corruption, government purchases of pharmaceuticals must generally be conducted with a high degree of transparency, and all quantities and pricings of purchased products must be disclosed.

 

9. How is the manufacturing of medicines and devices regulated and by which agencies?

The manufacturing of pharmaceutical products and medical devices is regulated by the following agencies:

• The Drug Division is responsible for the approval of manufacturing licenses for medicines.
• The Medical Devices Control Division is responsible for the approval of manufacturing licenses for medical devices.

After obtaining a manufacturing license, the license owner’s buildings and facilities will be inspected by a regulator in order to (1) determine the sufficiency of facilities and personnel to manufacture the medicine or medical device; and (2) assess compliance with the Pharmaceutical Inspection Cooperation Scheme (PIC/S) Good Manufacturing Practices (GMPs), or Thai GMP/ ISO13485 for medical devices.

In the event that the regulator finds that a licensee has violated any provision under the Drug Act or Medical Device Act, the regulator can suspend or revoke the manufacturing license.

 

10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the U.S. Food & Drug Administration and/or the European Medicines Agency (EMA)?

Yes, the Thai FDA has implemented PIC/S GMPs as a requirement for local drug manufacturers, and this requirement is compatible with definitions laid out by the U.S. FDA and the EMA. In general, both local and foreign manufacturers must comply with GMPs.

 

11. What is the inspection regime for manufacturing facilities?

Manufacturers must ensure that all activities in their facility comply with the requirements of PIC/S GMPs. In addition, the manufacturer must prepare a site master file, and Standard Operation Procedure (SOP). The frequency of the inspection will be 1 year, 2 years, or 3 years, depending on the results of the risk assessment. The Thai FDA inspector will assess two main aspects; namely the General aspect, and Production and Quality control aspect. After the audit is complete, the Thai FDA inspector will send an audit report to the drug manufacturer within 15 days.

If the inspector found critical or major defects, the GMP certificate will not be granted for the manufacturer. The manufacturer must then send a Corrective Action and Preventive Action (CAPA) report to the Thai FDA inspector within 15 days for reconsideration. The FDA inspector will follow up on any improvements made and may perform an additional inspection.

 

12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?

Yes, manufacturing facilities are open for inspection by foreign or third-party inspectors.

The Thai FDA has delegated some work, such as onsite inspections and evaluations of technical documents, to external experts from local or overseas agencies who have been approved by and are registered/listed with the Thai FDA.

 

13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?

The Drug Act and the Medical Device Act are the main acts regulating the requirements for storage, packaging, and handing of medicinal products and medical devices, respectively.

With regard to modern drug importation, a responsible pharmacist must always be present during business hours, as they will be responsible for monitoring, recording, and maintain proper storage of drugs.

All medicinal product and medical device storage facilities must display a signboard that reads “Place for Storage of Drugs/Medical Devices.” The storage room must be enclosed by walls and must have a door. Any doors or walls that are made of transparent glass should be covered with a dense film the inside of the storage room cannot be seen from the outside. The storage room floor must be made of a material that will not collect dust. Finally, the storage room must have shelves in order to designate a separate place for each type of product. 

For product packaging, labelling is mandatory. The labelling information that is to be used for the products must be submitted to the Thai FDA during the product registration process. Under the Drug Act, this labelling information can be submitted in the form of a package insert, a summary of the product’s characteristics, or a patient information leaflet.

Furthermore, the Thai FDA periodically issues Notifications prescribing specific required information that must be included on the label of specified drugs such as antibiotics, antihistamines, sedatives, etc.

 

14. What information must be included in medicine and device labelling?

Pharmaceutical-product Labelling

Product label information and the size of the whole package are mandatory documents that must be submitted to the FDA to obtain marketing approval. Under the Drug Act, labelling information can be submitted in the form of a package insert, a summary of the product’s characteristics, or a patient information leaflet.

The required information for package inserts is listed below:

• Product name
• Name and strength of active ingredients
• Product description
• Pharmacodynamics/pharmacokinetics
• Indications
• Recommended dose
• Instructions for use (including modes of administration, contra-indications, general warnings and precautions, interactions with other medical products, warnings and precautions for pregnant and lactating women, undesirable effects, and possible overdose and treatment)
• Dosage forms and packaging available
• Name and address of manufacturing/marketing authorization holder
• Date of revision of package insert

 

Package labelling must contain:

• Product name
• Dosage form
• Registration certificate number
• Composition or active ingredient with the quantity, unit, or strength.
• Pack sizes
• Lot/batch number
• Manufacturer’s name and country of origin
• Date of manufacture
• If applicable, and on a red label, a statement that the drug is classified as a specially controlled drug, dangerous drug, or common household drug in Thailand
• Expiration date and the word “expiry” in Thai

 

Medical Device-product Labelling

On Nov 5, 2020, the Ministry of Public Health published the Notification Re: Rules, Procedures and Conditions for Labels and Package Inserts of Medical Devices, which will be fully implemented 360 days from the date of publication date (i.e., October 31, 2021). According to this Notification, the medical device companies must prepare medical device package inserts that include the following information from October 31, 2021, onwards.

• Product name
• Product description (i.e., type, category, components, principles, etc.)
• Indications/intended Use
• Weight/amount (packing size)
• Manufacturer’s name and address or importer’s name and address (in case of imported product, the label must also indicate the name and address of the overseas manufacturer)
• Instructions for use
• Storage conditions
• Warnings, precautions, and contradictions
• Revision date
• Other statements or specific warnings, as required for certain medical devices (i.e., “Single-use only”, “Sterile product”, “Store away from sunlight”, “This is not for self-testing”, etc.)

 

In addition, labels for medical devices must include the following;

• Product Name
• Product description (i.e., type, category, components, principles, etc.)
• Indications/intended Use
• Weight/amount (packing size)
• Manufacturer’s name and address or Importer’s name and address (in case of imported product, the label must also indicate the name and address of the overseas manufacturer)
• Contact address for more information or complaints
• Instructions for use
• Storage conditions
• Warnings, precautions, contradictions
• Registration number
• Batch number or serial number
• Manufacturing date or expiry date showing the year as 4 digits
• Other statements or specific warnings, as required for certain medical devices (i.e., “Single-use only”, “Sterile product”, “Store away from sunlight”, “This is not for self-testing”, etc.)

 

15. What additional information may be included in labelling and packaging?

Any information that does not violate other legal requirements, such as advertising regulations, and does not infringe a trademark or copyright.

 

16. What items may not be included in labelling and packaging?

Any information that infringes upon other legal requirements, such as comparative advertising, exaggerating statements, or unauthorized use of a trademark.

 

17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?

Advertising Requirements for Pharmaceutical Products

Sections 88–90 of the Drug Act, B.E. 2510 (1967), as amended, and the Regulations of the Thai FDA’s Rules on Advertisements of Drugs for Sale B.E. 2545 (2002) (Advertisement Rule) are the main pieces of legislation governing the advertisement of pharmaceuticals in Thailand. Advertisements targeted at the general public and/or at health care professionals are subject to Thai FDA review and approval before dissemination. The advertising license is valid for a period of five years and is non-renewable.

 

Advertising Restrictions for Pharmaceutical Products

Advertisements for prescription or pharmacy-dispensed medicines can only be targeted at medical professionals. Pharmaceutical products in the household remedy category, which is called over-the-counter (OTC) in other jurisdictions, can be advertised directly to consumers and the general public; however, that advertising is subject to Thai FDA review and must be in accordance with Sections 88-90 of the Drug Act, the Consumer Protection Act, B.E. 2522 (1979), Thai FDA Regulation: Advertisement Rule, and the PReMA Code.

Advertisements must not:

• Boast that a medicine can miraculously or absolutely treat, cure, or prevent a disease or illness;
• Exaggerate or falsely declare properties of the medicine;
• Give the impression that the drug has a substance as its chief or component ingredient that it does not have, or has in a lower quantity than is believed to be present;
• Give the impression that it is an abortifacient or a strong emmenagogue;
• Give the impression that it is an aphrodisiac or a birth control drug;
• Advertise specially controlled drugs or dangerous drugs;
• Contain certification or endorsement of the drug’s therapeutic properties by any other person;
• Show its therapeutic properties as being capable of curing, mitigating, treating, or preventing diseases (or symptoms) as notified by the MOPH under Section 77 of the Drug Act (e.g., diabetes, cancer, paralysis, tuberculosis, leprosy and disease, or health conditions regarding brain, heart, lung, liver, spleen and kidney); or
• Advertise impolitely, by means of singing and dancing, or by showing the distress or suffering of a patient.

 

Advertising Requirements of Medical Devices

Sections 56-60 of the Medical Device Act, B.E. 2551 (2008), as amended, and the Notification of the FDA Re: Prescription of Rules, Procedures and Conditions for Filing Medical Device Advertisement Application, Issuance of a License for Advertising a Medical Device and Validity of a License for Advertising a Medical Device B.E. 2564, are the main pieces of legislation governing the advertisement of medical devices. Advertisements targeted at the general public are subject to Thai FDA review and approval before dissemination. The advertising license is valid for a period of three years and is non-renewable.

According to the Notification of the Ministry of Public Health: Rules, Procedures and Conditions for Medical Device Advertisements Directed towards Medical Professionals and Public Health Officials, which are Exempt from Approval, dated November 2, 2020, medical device advertisements directed at medical professionals and public health officials can be exempt from approval if the medical devices meet the following criteria:

• Medical devices that receive market authorization approval for manufacturing, importation, or sale; or
• Medical devices that receive an exemption for manufacturing, importation, or sale in accordance with Section 27(1), 27(2), 27(3), 27(4), 27(5), 27(6) and 27(8) of the Medical Device Act B.E. 2551 (2008), as amended.

 

Nonetheless, the advertisers must first notify the Thai FDA by submitting:

1. The advertisement notification (Jor Kor form); and
2. The advertising material via the Thai FDA’s electronic portal. In addition, the advertiser must secure access to only medical professionals and public health professionals.

 

Additionally, the Ministry of Public Health also published the Notification: Characteristics of Medical Device Advertisements that do not Require Approval, dated November 5, 2020, which exempts from the approval process medical device advertisements which display only a tradename or trademark logo.

 

Advertising Restrictions for Medical Devices

A company or individual who wishes to advertise a medical device product must first obtain a medical device advertising license from the Medical Device Control Division and must comply with the requirements prescribed by the FDA.

The following types of advertisements of medical devices are prohibited:

• Advertisement of a medical device that is subject to a ban on manufacture, import, or sale
• Advertisement of a counterfeit, substandard, poor quality, or unsafe medical device
• Any advertisement which is false or uses exaggerated statements (e.g., using boastful or deceptive wording)
• Any advertisement that shows more details than specified in the product label or medical device documentation, unless supported by evidence or a reliable academic publication; such advertisement must not relate to details on the indication or purpose of medical device use.
• Any advertisement which shows endorsement or praise of medical device benefits by a person, whether directly or indirectly
• Any advertisement which offers a chance to receive a prize by any means
• Any advertisement that shows the ability to prevent, cure, relieve, or treat a disease (or symptoms of a disease) which is banned by a Notification from the Minister
• Advertisement of a medical device name which is boastful, false, deceptive, misleading, or contrary to good morals and Thai tradition
• Any advertisement that is impolite or may cause disharmony or disunity among the people
• Any advertisement which discredits or provides a comparison to a medical device of another operator, except for comparisons to one’s own products or academic comparisons; in any event the name of a medical device or product technology of other persons must not be mentioned.

 

18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?

The channel of distribution of drugs are differ depending on their classification:

1. Household remedies can be sold anywhere, because a sales license is not required.
2. Pre-packed drugs that are not dangerous or are not specially controlled drugs (i.e., OTC drugs) can be sold in drugstores and can be purchased by consumers without being dispensed by a licensed pharmacist.
3. Dangerous drugs can be sold without a prescription but must be dispensed by a licensed pharmacist.
4. Specially controlled drugs which may possess a potentially harmful effect on health, if misused, are dispensed by prescription only. Some specially controlled drugs are only available in a hospital.

Medicinal products and medical devices can be delivered via post, but the online sell of medicines, except household remedies, is not yet allowed in Thailand.

 

19. What are the restrictions and requirements for electronic marketing and advertising via email, by Internet, social media, and other channels?

For any non-household remedy drugs, all direct-to-consumer marketing activities are prohibited under the Drug Act. Therefore, only household remedy drugs can be advertised directly to consumers and the general public.

While the law does not expressly limit the types of advertising activities for household remedy drugs, the Thai FDA must provide permission for the picture, sound, or text, use in the advertisement before they are featured on radio, television, motion pictures, printed materials, or internet media. Advertisements for household remedy drugs must in comply with the advertising conditions set by the Thai FDA (see question 3.17, above).

The PReMA Code provides a guideline that patient education material should be distributed for educational purposes and should encourage patients to seek further information or explanation from an appropriate healthcare professional. Therefore, hotlines, websites, or other similar information services can be set up to provide general information that useful to the public. Such services must strictly be general and cannot include any promotional information or personal medical advice.

 

20. May medicines and devices be advertised or sold directly to consumers?

Pharmaceutical products

Both household remedy drugs and OTC drugs can be sold and advertised directly to consumers or the general public. However, such advertising is subject to Thai FDA review and approval before dissemination (see question 3.19 above for more information).

Drugs classified as dangerous or specially controlled drugs cannot be advertised directly to consumers or the general public; however, they can be advertised to medical practitioners.

 

Medical devices

Medical devices can be advertised directly to consumers, medical practitioners, or both, depending on the license applied for and the license granted by the Thai FDA. As of today, advertisements targeted at the general public must obtain approval from the Thai FDA before being disseminated. However, advertisements directed at medical professionals and public health officials can be exempt from approval. In such cases, the advertiser must first notify the Thai FDA by submitting an advertisement notification together with the proposed advertisement material.

 

21. How is compliance monitored?

The agencies responsible for monitoring marketing activities are:

1. The Thai FDA under the supervision of the MOPH, and
2. The Office of the Consumer Protection Board of Thailand under supervision of Prime Minister’s Office.

The FDA will conduct site visits and online investigations when they come across any advertising violations or complaints. In the event of a site visit or online investigation, a notice will be sent to the advertiser requesting an explanation or defence of their case.

 

22. What are the potential penalties for noncompliance?

Pharmaceutical Products

The Secretary-General of the Thai FDA can issue a written order to cease any advertisement deemed to be contrary to the Drug Act. If is determined that the advertisement misled the public, the Thai FDA can order the violator to issue a corrective advertisement.

Any violation of the Drug Act’s marketing provisions is subject to a fine of up to THB 100,000. The calculation of the fine will depend on the amount of time it takes the advertiser to act after receiving a warning or notice of violation, and the number of occurrences of other wrongdoings. For example, if a promotional booth uses three posters and two gimmick gifts that were never been submitted for FDA approval, they could be fined for a combination of the five offences.

For PReMA members, if a complaint regarding a breach of the PReMA Code is filed by another PReMA member, the complaint will be administered by the PReMA Chief Executive Officer and the Code of Conduct Committee, which has the power to sanction its members.

 

Medical Devices

Any person who advertises a medical device without approval, will be liable to imprisonment for a term not exceeding six months, a fine not exceeding THB 50,000, or both, per Section 116 of the Medical Device Act, as amended.

Also from this Legal Handbook

1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?

In April 2019, the Thai FDA published and implemented the Herbal Product Act. This is now the main act regulating herbal or traditional medicine in Thailand.

The authorization process for the marketing of traditional medicines and herbal products is similar to that of other health products. Prior to product registration, any party who wishes to import or manufacture an herbal product must register its place of business as an herbal product importer or herbal product manufacturer with the Thai FDA. Subsequently both the importer and manufacturer can register and obtain a license/certificate for importation or manufacturing of the specific herbal product.

Pursuant to the Herbal Product Act B.E. 2562 (2019) and Ministerial Regulation Re: Registration of Herbal Products B.E. 2563 (2020), herbal products can be classified into three categories, determined by the risk level of the indications/health claims and the policies of the government authority.

 

(1) Notification (Listed) Herbal Product (Low Risk)

The requirements for Notification Herbal Products are the least stringent. Herbal products under this category must be well established, widely used, and have bibliographical evidence. The Thai FDA has published a list of “official formulations” that are recognized as Notification Herbal Products in the FDA Guideline (available on the Thai FDA website). The validity of a Notification Herbal Product certificate is five calendar years and is renewable.

 

(2) Detailed Notification Herbal Product (Moderate Risk)

Herbal products in this category are subject to a less intensive review procedure than Licensed Herbal Products. Detailed Notification Herbal Products are products adapted from the official formulation of Notification Herbal Products e.g., combinations of the active ingredients that are listed as the official formulation. The validity of a Detailed Notification Herbal Product certificate is five calendar years, and it is renewable.

 

(3) Licensed Herbal Product (High Risk)

This is the most strictly controlled class of herbal products. Any herbal product that does not qualify for classification as a Detailed Notification Herbal Product or a Notification Herbal Product will fall under this classification. The validity of a Licensing Herbal Product certificate is five calendar years and is renewable.

Requirements on licensing, product registration/notification, official classification, and other related topics are available in the following notifications:

• Ministerial Regulation RE: Applying and Issuing of License for Manufacturing, Importing and Selling Herbal Product B.E.2563 (2020)
• Ministerial Regulation RE: Registration/Notification of Herbal Product B.E.2563 (2020)
• FDA Notification RE: Application Form and License Template for Manufacturing, Importing and Selling Herbal Product B.E.2563 (2020)
• FDA Notification RE: Application Form and License Template for Registration/Notification of Herbal Products B.E.2563 (2020)

 

2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?

Yes, herbal medicines can be advertised directly to the public, but an advertising license is required. Any advertisement for herbal medicines must comply with the advertising conditions prescribed in the accompanying Ministerial Notifications RE: Rules Procedure and Condition for Advertisement of Herbal Products B.E. 2564 (2021).

 

3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?

Advertising and marketing claims for herbal products must comply with the advertising conditions prescribed in the Ministerial Notifications. In addition, any statements or information provided in an advertisement must not go beyond what is provided on the product label, leaflet, or packaging.

In general, any claim is acceptable, as long as it does not:

• Boast that herbal products can miraculously or absolutely treat, cure, or prevent a disease or illness;
• Exaggerate or falsely declare properties of herbal products;
• Exaggerate or falsely declare the price of herbal products;
• Give the impression that the herbal products have a substance as its chief or component ingredient that it does not have, or has it in a lower quantity than is believed to be present;
• Give the impression that it is an abortifacient or a strong emmenagogue;
• Give the impression that it is an aphrodisiac or a birth-control drug.

 

4. What are the regulatory requirements for over-the-counter (non-prescription) medications?

The regulatory requirements for household remedy drugs (OTCs) are the same as those for other drugs, and the Drug Act, as amended, is the main legislation that regulates them.

Before launching OTC products into the market, an importer or manufacturer will need to obtain three licenses/approvals from the FDA:

1. An import or manufacturing license;
2. An approval for sample product importation and approval for GMP Clearance of the overseas manufacturing site; and
3. Market authorization license.

Because there are no limitations on the channel of distribution for OTCs, they can be sold anywhere (e.g., supermarket, online, etc.) and the seller does not need to obtain a license to sell them.

 

5. Are there any limitations on locations or channels through which OTC products may be sold?

No, there are no limitations of the channel of distribution for OTC products.

 

6. What health, advertising, and marketing claims may be made for OTC products?

OTC products are subject to the same advertising and marketing restrictions mentioned in question 3.17 (above).

 

7. Can OTC products be marketed or advertised directly to the public?

Yes, OTC products can be marketed or advertised directly to the public, once the advertisement has been approved by the Thai FDA.

 

8. What is the mechanism by which a prescription-only product can be converted to an OTC product?

In order to convert from a prescription-only product to an OTC product, the licensee must submit a reclassification letter, together with safety data, to the Secretary-General of the Thai FDA.

 

9. What are the requirements for the importation of either traditional medicines or OTC products?

First and foremost, an import license must be obtained before any import activity takes place. In order to obtain an import license for traditional medicines or OTC products, the applicant must:

1. Be the owner of the business, and have sufficient assets and structure to be able to establish and operate the business;
2. Be at least 20 years of age;
3. Be a resident of Thailand;
4. Not have been convicted for an offence against certain laws (e.g., laws concerning narcotics and psychotropic substances);
5. Have the premises to produce, sell, import, or store drugs and equipment for use in the production, sale, or storage of drugs, and the control or maintenance of drug quality and quantity as prescribed in ministerial regulations;
6. Use a trade name for the drug business that is not a repetition of, or similar to, a trade name used by another active licensee or a licensee whose license has been suspended or revoked for less than a full year.

After a license has been obtained, both OTCs and traditional drugs must be registered with the Thai FDA before they can be distributed in Thailand.

Also from this Legal Handbook

1. What types of liability are recognized in your jurisdiction?

The laws of Thailand provide for civil, criminal, and administrative liabilities.

Fundamentally, product liability is recognized as part of sales and contract law wherein the seller shall be liable to the buyer for a damage caused by deficient goods. This liability may be waived by a contract.

For consumer goods, the Consumer Protection Act and the Unsafe Goods Liability Act limit the seller’s ability to exclude civil liability arising from a product being sold. If it has been established that the product is unsafe, then the seller shall be strictly liable regardless of whether such unsafety was caused by the seller’s negligence or by intentional action or omission.

Specifically, in the context of medical products, the Drug Act and the Medical Device Act set criminal liabilities for selling fake or substandard products, among others. Administrative sanctions, including suspension or termination of a business operation permit, apply as well.

 

2. How do these types of liabilities apply to the manufacturers of medicines and devices?

Because of the territoriality rule, a manufacturer based in Thailand may be enforced for any of the above liabilities.

While a direct enforcement against an overseas manufacturer may be problematic, Thai authorities can effectively block products originating from overseas manufacturers by revoking marketing authorizations, coordinating with the customs authority at the ports of entry, and bringing enforcement actions against the Thai importer who attempted to import such products.

 

3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?

The abovementioned liabilities (except those concerning operation permits) may extend to individual executives, employees or representatives; however, this is not a strict liability. To hold an individual liable, the complainant is required to prove that such individual’s action/omission caused the injury or the violation of the applicable law.

For civil liability, the standard of proof is “by balance of probabilities;” for criminal liability, the standard of proof is “beyond a reasonable doubt.”

 

4. How can a liability claim be brought?

The injured consumer may bring their complaint to the competent authority, which includes a civil and commercial court (Consumer Case Procedure Act, B.E. 2551 (2008)) or a consumer protection organization. A class action is also possible.

Specifically, in the context of drugs and medical devices, such competent authority also includes the Thai FDA.

 

5. What defences are available?

For civil liability, the Unsafe Goods Liability Act provides several defences for the defendant. Notable defences include the following:

1. The product was in fact not unsafe.
2. The injured party (e.g., the consumer) was aware that the product was unsafe but used it anyway.
3. The damage was due to improper use or storage of the product, and the defendant provided reasonably clear and accurate instructions for use and storage.

Also from this Legal Handbook

1. What are the basic requirements to obtain patent and trademark protection?

Patent

The “subject matter” contained in a patent application may be patented if the following requirements are met:

1. Novelty: Before the filing date, the subject matter must not have been publicly used anywhere in Thailand, and the details of the subject matter must not have been published anywhere in the world.

1. Inventive Step. The subject matter must not be obvious for a person with ordinary skills in the relevant technical field.
2. Industrial applicability. The subject matter must be useful for industry (which includes commerce, agriculture, and handicrafts).

In addition to the basic requirements, there are particular subject matters which are not patentable by nature. Please refer to question 6.3 (below) for more details.

 

Trademark

A trademark is registrable if the following requirements are met:

1. It is distinctive;

1. It is not prohibited under the Trade Mark Act, B.E. 2534 (1991), as amended, (refer to question 6.3 for more details); and
2. It is not identical or similar to a Thai trademark already registered by a third party.

Further, sound identifiers that are not the natural sound of, or caused by the functioning of the respective goods, and shapes of three-dimensional objects that are not the natural shape of the respective goods, may be registered as Thai trademarks.

 

2. What agencies or bodies regulate patents and trademarks?

The competent regulators and registrars are the Thai Patent Office and the Thai Trademark Office, both operating under supervision of the Department of Intellectual Property, Ministry of Commerce.

 

3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?

Patent

Pharmaceutical inventions are treated similarly to inventions in other technical fields. To be eligible for a patent, a pharmaceutical invention must meet the basic requirements per question 6.1 (above).

In addition to those requirements, the following subject matters are not patentable:

1. Micro-organisms that naturally exist and their components, animals, plants, or crude extracts from animals or plants;

1. Scientific and mathematical rules and theories;
2. Computer programs;
3. Methods for diagnosing, treating, or curing human or animal diseases; and
4. Inventions that are contrary to public order or morality, public health, or welfare.

In the context of drugs and medical devices, (1), (4), and (5) are of particular note.

Generally, the following can be patented if it is novel, has an inventive step, and if it is industrially applicable:

• Polymorphic forms
• Formulations
• New therapeutic use of a known chemical compound (e.g., a second medical use)
• Combination and dosage form
• Methods for preparing medicinal products or related substances

 

Trademark

A brand of medical products may be registered as a Thai trademark without a special requirement for medical products. The main restriction is that the mark must not be similar or identical to an international non-proprietary name (INN), which in fact is part of the basic requirement of distinctiveness.

In addition to the basic requirements (see question 6.1, above, for more details), the following marks, among others, are prohibited from trademark registration:

1. State arms or crests, royal seals, official seals, Chakri dynasty emblems, emblems and insignia of the royal orders and decorations, seals of office, seals of ministries, bureaus, departments, or provinces.
2. National flags of Thailand, royal standard flags, or official flags.
3. Any mark which is contrary to public order, morality, or public policy.
4. A mark which is identical with, or confusingly similar to, a mark that is well-known in Thailand, regardless of whether such well-known mark has been registered.
5. How can patents and trademarks be revoked?

 

Patent

The validity of a patent may be challenged by filing an invalidation claim with the Intellectual Property and International Trade Court (IP & IT Court). The IP & IT Court may revoke a patent if one of the following applies:

• The invention is not new, lacks an inventive step, or is not capable of industrial application.
• The subject matter of the invention is not patentable (see question 6.3, above).
• The patent applicant did not have the right, or was not eligible, to apply for the patent (e.g., was not the actual inventor and not the inventor’s assignee).

 

Trademark

A trademark may be revoked by the Trademarks Board or the IP & IT Court if, among others, such trademark does not comply with the aforementioned legal requirements (questions 6.1 and 6.3, above); there is a continuous three-year period of non-use; or such trademark has become a generic reference to the product or service and thereby has lost its distinctiveness.

 

5. Are foreign patents and trademarks recognized and under what circumstances?

Patent

A foreign patent is not directly enforceable in Thailand. However, foreign patents are always recognized as prior arts which may be cited against a Thai patent’s validity.

 

Trademark

A foreign trademark is not directly enforceable in Thailand. However, if such foreign trademark has attained the status of a well-known mark in Thailand (e.g., by use or promotion), it can be cited against a Thai trademark’ validity (see the question 6.3, above).

 

6. Are there any non-patent/trademark barriers to competition to protect medicines or devices?

No.

Thailand only recognizes physical protection of the documentation submitted to the Thai FDA as trade secret protection. In relation to data or information submitted to the Thai FDA by a drug originator to obtain approval to market a new drug, the Trade Secrets Act, B.E. 2545 (2002), as amended, recognizes that such data or information, in whole or in part, may amount to a trade secret in the form of a testing result, or other information regarding its preparation, discovery, or creation. In this case, the owner has the right to request that the Thai FDA maintain the confidentiality of the data submitted.

Upon receiving such request, the Thai FDA must keep such data confidential for a period of five years. However, the Thai FDA takes the position that it only has a duty to keep the drug originator’s data on file confidential and protect it from physical disclosure, while it can still rely on such data to assess and approve a subsequent generic application.

The above the trade secret protection applies to drug products only. Medical devices are not covered by this framework.

 

7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?

Other than the basic requirements covered in question 6.1 (above) and prohibitions covered in question 6.3 (above), there are no further restrictions specific to drugs or medical devices.

 

8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?

A patent or trademark licensing agreement must be recorded with the Thai Patent Office or Thai Trademark Office to be effective. The agreement will be reviewed under prescribed criteria. Notably, (1) a patent licensing agreement must not contain a provision that effects an unfair trade restriction; (2) a trademark licensing agreement must enable the trademark owner to control the quality of respective product or service; and (3) implementation of such license must not mislead or confuse the public.

There are no additional requirements for a foreign licensor.

Also from this Legal Handbook

1. Are there proposals for reform or significant change to the healthcare system?

Significant changes to the healthcare system include the following:

The Patent Act

The Patent Act is currently under review and final revision by the Department of Intellectual Property, and is expected to be passed soon. The Act’s amendments aim to update Thai patent law according to international agreements and standards. Areas for amendment include:

• Reducing the long periods of pendency for patent registration and improving the patentability and enforceability of petty patents.
• Accepting the Protocol Amending the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) regarding Thailand’s public health.
• Facilitating Thailand’s accession to the Hague Agreement regarding design protection.

 

The Narcotics Code (2021)

The notable effects of the Narcotics Code are as follows:

• Consolidation of the previous Narcotics Act, Psychotropic Substances Act, and other legislation related to the control and suppression of substance abuse, and cancellation of said legislation.
• Implementing regulations promulgated under the cancelled legislation maintain their effect pursuant to the Narcotics Code’s transitional provisions, until the new Regulations addressing the same subject are promulgated.
• On June 9, 2022, the Minister of Public Health issued a Ministerial Notification under the Narcotics Code, delisting cannabis and hemp plants, along with their unprocessed parts, from the purview of the code.
• The specialized Cannabis and Hemp Act is expected to be promulgated in 2025 to control the activities related to now non-narcotic cannabis and hemp.
• Licenses and regulatory approvals issued under the said cancelled legislations maintain their effects pursuant to the Narcotics Code’s transitional provisions, until the expiry of said approvals.

 

The Drug Act, 6^th Amendment B.E. 2562 (2019) and Notification of Thai FDA: Patent Declaration Form

According to the implementation of the Drug Act (6th Amendment) B.E. 2562 (2019), and Notification of Thai FDA: Applicants who wish to register a modern drug are now required to submit a patent declaration form (Ror 1 form) together with the drug registration application.

 

Implementation of Good Distribution Practice (GDP) for Drug Manufacturers and Drug Importers

From January 2, 2021, onwards, Good Distribution Practice (GDP) has been officially adopted as a required standard in Thailand. Thus, thus drug manufacturers and importers are required to pass GDP inspections in order to new their manufacturing or import licenses.

 

2. When are they likely to come into force?

Prospective developments in drug and medical device legislation include the following:

Renewal of Drug MA License

MA license holders must submit their applications for renewal of MA licenses before the license’s expiry date. Following the review of the technical documents, the FDA will renew the license with a validity of seven years.

 

Quality System of Medical Devices

The following Notifications of the Ministry of Public Health (MOPH) and the Thai FDA about quality management systems of medical device manufacturing and Good Manufacturing Practice (GMP) have been effective since 3 July 2024:

• MOPH Notification: Quality Management System of Medical Device Manufacturing
• FDA Notification: Rules, Procedure, and Conditions for Medical Device Good Manufacturing Practices (GMP)

According to these Notifications, domestic medical device manufacturers must have and control their manufacturing process to be in compliance with one of the quality management systems below:

(1) Medical Device Good Manufacturing Practices (GMP) − must align with the Thai Conformity Assessment Standard called “Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes No. Mor Tor Chor 13485-2562” or the latest updated version.

(2) ISO 13485:2016 or Medical Device Quality management system – Requirements for regulatory purposes – ISO 13485:2016

(3) Other quality management system standards certified by foreign government authorities that are recognized by the Thai FDA

 

 

Also from this Legal Handbook

1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies?

Yes. Pursuant to Section 12 of the Drug Act 1967, as amended, any domestic manufacturing, importing or ordering into Thailand, including the distributing of active pharmaceutical ingredients, intermediate and bulk medicinal products, and finished medicinal products is subject to authorisation from the Thai Food and Drug Administration (FDA). The licenses for domestic manufacturing, importation and distribution are valid for one calendar year. The license must be renewed before 31 December each year. Following the obtaining of the license, the manufacturer or importer must submit the registration dossier of the medicinal product intended to be manufactured or imported into Thailand, pursuant to Section 80 of the Drug Act.

The Thai FDA only grants manufacturing/importation/distribution licenses to entities with a physical address in Thailand. Foreign applicants may be able to obtain authorisation if they have a branch office in Thailand.

 

Clinical Trials

The clinical trials are not required to be conducted locally as a condition for obtaining marketing authorization in Thailand.

 

2. Have there been any recent significant changes involving localization rules? If yes, when did they take place and what did they involve?

There have not been any recent significant changes involving localization.

 

3. Is the process of obtaining a marketing authorization impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

Yes, the process of obtaining marketing authorization is impacted by localization policies, as medicinal products may only be marketed in Thailand if a marketing authorisation license has been granted by the Thai FDA, as prescribed in the Drug Act.

Foreign marketing authorizations are not recognized in Thailand. However, the Thai FDA requests that the importer submit a Certificate of Free Sale (CFS) or Certificate of Pharmaceutical Product (CPP), as issued by the regulatory authority in the manufacturing country as part of the dossier requirement. Without the CFS or CPP, the Thai FDA may not approve the marketing authorization license. The Drug Act provides that applicants for and holders of marketing authorizations must be established in Thailand.

 

4. Is the pricing process for pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

No. Both domestic manufacturers and importers who place medicinal products on the market are free to determine the prices for their medicinal products when selling to wholesalers, healthcare professionals, pharmacies and/or other authorised retail sellers.

 

5. Is the reimbursement of pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

The reimbursement of pharmaceutical products is not impacted by localization policies in Thailand.

 

6. Is the access to public or public tenders of pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

No. In a state agency’s procurement procedure in Thailand, public hospitals may require the tenderer to have the necessary authorizations to market the products concerned. As mentioned in our answer to question 114, marketing authorization license is granted to a company established in Thailand. Therefore, such pharmaceutical company can be the contracting party with the public hospitals.

 

7. Are import tariffs, importation and/or exportation permits, trade and/or taxation of pharmaceutical products impacted by localization policies in your country? If yes, how so?

No.

 

Import and Export

Please see question 114 above. Any importation/exportation of medicinal products is subject to marketing authorisation from the Thai FDA. The Thai FDA only authorises companies with physical presence in Thailand.

 

Taxation and Import Tariffs

Thailand’s Board of Investment (BOI) offers both tax and non-tax schemes for companies involved in research and development. In principle, the BOI maintains a policy of giving special consideration to investment projects that promote economic clusters to create and concentrate investment in accordance with Thailand’s potential and to strengthen value chains, as well as to promote investment in specific areas in Thailand, such as the Eastern Economic Corridor and southern border areas of Thailand. Biological products and vaccines are one of the clusters in biofuels and biochemicals that the government is promoting. Additionally, BOI-promoted companies may be granted exemptions for import tariffs on imported goods.

 

8.. Are there any other incentives or advantages offered by the current local localization rules in your country? If yes, what are they?

Since December 21, 2020, the BOI has approved a series of stimulus packages aimed at encouraging both local and foreign investment, as the government seeks to boost Thailand’s economic recovery from the COVID-19 pandemic. Biological drugs and vaccines are targeted industries, which will be entitled to an additional corporate income tax deduction for a period of five years.

 

9. Are there discussions about the possibility of implementing localization policies in your country? If yes, what are the proposed reforms and when should they come into place?

There are currently no on-going discussions about the possibility of implementing further localization policies in Thailand.

 

THAILAND	Research	Clinical Trials	API Content	Fill and Finish	Packaging
Require/Benefit	B	0	R	R	R
Requirement
Benefits	TX		MA	MA	MA

Line 1 

0 – if neutral

R – if a requirement

B – if provides benefit

Line 2 and 3 Fill in (according to answer in Line 1)

MA – Market Access

P – Pricing

R – Reimbursement

T – Tenders

Tx – Taxes and import tariffs

Also from this Legal Handbook

Chapter 9: Cannabinoid Drugs

1. Are Cannabinoid Drugs authorized in your country?

For the purpose of this chapter, cannabinoid drugs are drugs containing a cannabinoid, which may be extracted and purified from a cannabis plant or synthesized by other means without involving a cannabis plant.

The formulations of cannabinoid drugs may be applied for regulatory approval via the pathways under the Drug Act or the Herbal Product Act.

The manufacturer or importer must have a relevant license to operate in order to have a standing to apply for approval of the formulation (i.e., product license).

 

2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?

The Thai Food and Drug Administration (Thai FDA).

 

3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?

Authorization of cannabinoid drugs follows the registration pathways of either the Drug Act or the Herbal Product Act, and any ministerial regulations or notifications issued pursuant to these laws. There are eight traditional medicines containing cannabis listed in the National List of Essential Medicines. Patients can receive these formulas free of charge at hospitals.

 

4. Which are the cannabinoid drugs that have received market approval to date?

The eight traditional formulas of cannabis, as mentioned in the above question 8.3, are currently available in hospitals under the Special Access Scheme (SAS).

 

5. Who can prescribe Cannabinoid Drugs?

Cannabinoid drugs may be prescribed by licensed medical doctors, dentists, and Thai traditional doctors.

 

6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?

A list (in Thai) of individuals who have successfully completed training programs on traditional Thai drug formulas using cannabinoid ingredients can be found at http://hemp.fda.moph.go.th/FDA_MARIJUANA​/SAS/VISIT_DOCTOR.

 

7. What approvals or notifications are required to prescribe Cannabinoid Drugs?

The medical professionals mentioned in question 8.5 can prescribe cannabinoid drugs under the SAS. No prior approval or notification is required.

 

8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?

Hospitals, the Thai Government Pharmaceutical Organization, the Thai Red Cross, and other public entities with duties relating to public health, provided that they have a relevant license issued by the Thai FDA, are authorized to sell and distribute cannabinoid drugs.

 

9. Is there a list of retailers/distributors authorized to sell Cannabinoid Drugs?

There is no official list of retailers or distributors authorized to sell cannabinoid drugs.

 

10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?

Notable proposals include the addition of more formulas of medical cannabis (including cannabinoid drugs) in the National Health Security system.

 

11. When are they likely to come into force?

Currently unknown.

 

 Medicinal Cannabis

12. Is Medicinal Cannabis authorized in the country?

No modern drug containing cannabis has obtained marketing authorization in Thailand so far. Cannabis formulas containing CBD, THC or a combination of the two and Thai traditional formulations are available via the Special Access Scheme.

 

13. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?

The Thai FDA.

 

14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?

Authorization of medicinal cannabis follows the pathways of the Drug Act or the Herbal Product Act, and any ministerial regulations or notifications issued pursuant to these.

There is no regulatory framework in relation to pricing of medicinal cannabis.

Regarding reimbursement, medicinal cannabis may be reimbursed by the state when the drugs are listed in the National List of Essential Drugs (NLED). Currently, eight herbal formulas containing cannabis as an active ingredient are listed in the Herbal NLED.

 

15. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?

Production and distribution of medicinal cannabis is regulated and licensed by the Thai FDA.

The manufacturer or importer must have a license to operate the business under the relevant law in order to have standing to apply for approval of a formulation (i.e., product license).

 

16. What approval or notifications are necessary to produce or import Medicinal Cannabis?

Licenses for medical cannabis production or importation, issued by the Thai FDA, are necessary to produce or import medicinal cannabis. Please see question 9.15 (above) for details.

 

17. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?

The previous chapter’s regulations on sale and distribution of cannabinoid drugs fully apply to medicinal cannabis:

Hospitals, the Thai Government Pharmaceutical Organization, the Thai Red Cross, and other public entities having duties relating to public health, provided that they have a license issued by the Thai FDA, are authorized to market and distribute medicinal cannabis.

 

18. How can patients obtain Medicinal Cannabis?

Patients may obtain medicinal cannabis through a prescription. The eight traditional formulas of cannabis mentioned in question 9.14 are currently available in the hospitals under the Special Access Scheme (SAS).

 

19. Who can prescribe Medicinal Cannabis?

Medicinal cannabis must be prescribed by a licensed medical doctor, dentist, or Thai traditional doctor, provided that the prescription is for the purpose of medical treatment.

 

20. Is there a list of doctors authorized to prescribe Medicinal Cannabis?

A list (in Thai) of individuals who have successfully completed training programs on traditional Thai drug formulas using cannabinoid ingredients can be found at http://hemp.fda.moph.go.th/FDA_MARIJUANA​/SAS/VISIT_DOCTOR.

 

21. What approvals or notifications are required to prescribe Medicinal Cannabis?

The medical professionals mentioned in question 9.19 can prescribe medicinal cannabis under the SAS. No prior approval or notification is required.

 

22. Where is Medicinal Cannabis available?

According to the present regulations, medical cannabis must be prescribed by a licensed medical doctor, dentist, or Thai traditional doctor.

Further, medical cannabis may be made available by hospitals, the Thai Government Pharmaceutical Organization, the Thai Red Cross, and other public entities having duties relating to public health, provided that they have a relevant license issued by the Thai FDA.

Additionally, international transportation service providers may make medical cannabis available for emergency treatment without a license.

 

23. Is there a list of retailers authorized to sell Medicinal Cannabis?

There is no official list of retailers/distributors authorized to sell medical cannabis.

 

24. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?

Notable proposals include the addition of more formulas of medical cannabis in the National Health Security system.

 

Opioid Drugs

1. Are Opioid Drugs authorized in your country?

For the purposes of this chapter, opioid drugs are drugs containing an opium derivative that are formulated for medical use (e.g., morphine and pethidine). Activities relating to this class of drugs—including production, importation, exportation, distribution (inclusive of prescription), and possession—are allowed for medical use under the Narcotics Code’s strict regulation.

Generally, formulations of medical opioid drugs must be approved under the Drug Act, while business operators (producers, distributors, etc.) must have a relevant license under the Narcotics Code to operate in connection with the narcotics.

 

2. What are the regulatory authorities with jurisdiction over Opioid Drugs?

The Thai FDA.

 

3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?

Authorization of opioid drugs follows the pathways of the Drug Act and the Narcotics Code, and any ministerial regulations or notifications issued pursuant to these laws.

Pricing of certain opioid drugs (e.g., morphine) is controlled by the Narcotics Control Division of the Thai FDA. Reimbursement for some opioid drugs is permissible for patients under the National Health Security System.

 

4. Which are the Opioid drugs that have received market approval to date?

A number of opioid drugs have received market approval in Thailand, such as morphine, fentanyl, codeine, and pethidine.

 

5. Who can prescribe Opioid Drugs?

Opioid drugs must be prescribed by a licensed medical doctor or dentist.

 

6. Is there a list of doctors authorized to prescribe Opioid Drugs?

There is currently no official list of doctors who are authorized to prescribe opioid drugs.

 

7. What approvals or notifications are required to prescribe Opioid Drugs?

Licenses for opioid drug distribution, issued by the Thai FDA, are required for hospitals that would like to dispense opioid drugs. Please see question 10.5 (above) for details.

 

8. Which organizations are authorized to sell/distribute Opioid Drugs available?

Hospitals, the Thai Government Pharmaceutical Organization, the Thai Red Cross, or other public entities, provided that they have a license for opioid drug distribution issued by the Thai FDA, are authorized to sell and distribute opioid drugs.

 

9. Is there a list of retailers/distributors authorized to sell Opioid Drugs?

There is no official list of retailers or distributors authorized to sell opioid drugs.

 

10. Are there proposals for reform or significant change to the regulation of Opioid Drugs?

There is no such proposal.

 

11. When are they likely to come into force?

Not applicable.

Also from this Legal Handbook

1. What is the definition of Rare Diseases in your country?

Neither the Ministry of Public Health in Thailand (MoPH) nor the Thai Food and Drug Administration (Thai FDA) has prescribed a definition for “rare diseases.” However, the Unit of Clinical Genetics, Department of Paediatrics, Faculty of Medicine at Mahidol University, an autonomous research institution and one of the most prestigious universities in Thailand, has provided a definition of rare or orphan diseases as “any disease that has a disease prevalence of less than one in 2,500 people, wherein there are limited drugs available for treatment of such disease.”

 

2. Does the designation of ‘Orphan Drug’ exist in your country? (Does it correspond with the definition of Rare Diseases?)

Yes, the Thai FDA has defined an “orphan drug” as:

(a) A drug needed for diagnosis, alleviation, treatment, prevention, or cure of:

• • a rare disease,
  • a seriously harmful disease, or
  • a disease resulting in continuing disabilities

(b) A drug with a low usage rate, wherein there is no other drug that can be utilized as a replacement, and there is also a shortage issue.

 

3. What is the regulatory framework for the authorization of an OrphanDrug? (Is this regulatory framework based on Rare Disease status or can it alternatively be based on Orphan Drug foreign status?)

Unlike the orphan drug status in other countries, the regulatory framework for orphan drugs in Thailand is based on both the status of rare diseases and drug shortage issues.

In 2013, the FDA published guidelines (in Thai language) regarding the registration of orphan drugs. Through these guidelines it was determined that the Subcommittee of Orphan Drugs, under the supervision of the National Drug Committee and coordinated by the Bureau of Drug Control of the Thai FDA, would be responsible for (a) providing and updating the list of orphan drugs, (b) creating thorough guidelines for orphan drug registration, and (c) developing a mechanism for increasing the accessibility of orphan drugs.

As provided in the guidelines, the Thai FDA announced a list of approved orphan drugs through the Food and Drug Notification Re: List of Orphan Drugs. The most recent notification was published in 2021, and includes the 82 orphan drugs that have been authorized for use in Thailand. See the full list of orphan drug via this link.

 

4. Does your country have provisions for relaxed clinical trial/scientific evidence requirements in respect of Orphan Drugsas compared to other drugs?

Yes. The Thai FDA has exempted some requirements for the evaluation of orphan drugs, particularly if the orphan drugs have had extensive usage in other countries or if they have been previously marketed in other countries. In such cases, the Thai FDA would allow the registration of the orphan drugs without the submission of preclinical or clinical modules.

 

5. Is there an expedited pathway for OrphanDrugs?

Yes. There is an expedited pathway for registration of orphan drugs in Thailand. An applicant can submit, together with a registration dossier, a cover letter requesting the Thai FDA to apply an expedited pathway for the registration of the orphan drug.

 

6. Are foreign marketing authorizations recognized in your jurisdiction for Orphan Drugs? If yes, marketing authorizations from which countries are recognized?

Yes. The Thai FDA allows an abridged evaluation, wherein the marketing authorizations from benchmark countries such as Australia, Canada, the EU, Japan, and the U.S. are well accepted.

 

7. Can OrphanDrugs be reimbursed? If so, is there a specific reimbursement procedure for Orphan drugs?

Orphan drugs can be reimbursed in Thailand, but the reimbursement scheme for each individual patient will determine which drugs they can receive reimbursement for. Currently, there are three main reimbursement schemes related to the healthcare system in Thailand.

• Civil Servant Medical Benefit Scheme (CSMBS): a scheme administered by the Comptroller’s Department of the Ministry of Finance that covers government officials and their dependents (spouse, parents, and up to three children).
• Social Security Scheme (SSS): a scheme administered by the Social Security Office, Ministry of Labour, that is applied to non-government workers and employees.
• National Health Insurance or Universal Coverage Scheme (UC): a scheme administered by the National Health Security Office (NHSO), Ministry of Public Health, that covers the remaining population not covered under the CSMBS or the SSS.

Patients under the CSMBS are eligible for reimbursement of almost all drug items, including orphan drugs. Patients under the SSS or the UC are also eligible for drug reimbursement; however, fewer orphan drugs are covered under these schemes. For all available schemes, there is no specific procedure in order to receive reimbursement for orphan drugs.

 

8. How are the prices of OrphanDrugs regulated?

Prices of drugs, including orphan drugs, are regulated when they are listed in a Notification from the National Drug System Development Committee, in which the “maximum allowable purchase price” will be prescribed for each drug. If a specific drug, including an orphan drug, is listed in said Notification, a public hospital can purchase the drug if the price is less than or equal to the maximum allowable purchase price.

 

10. Have there been any significant legal/judicial developments in relation to Orphan Drugsin your country?

The Council of Ministers of Thailand agreed to exempt importation tax on certain orphan drugs, with an aim to construct an accessible and secure drug system of Thailand. The Notification of the Ministry of Finance RE: Reduction of Tax and Exemption of Import Duties No. 2 and No. 3, published in the Government Gazette on January 20, 2019 and March 23, 2020, lists orphan drugs and raw materials for production of medical masks (medical devices) as product that are exempt from duty tax.

 

11. Are there proposals for reform or significant change to the regulation of Orphan Drugs? If yes, when are they likely to come into force?

As it stands now, the Government Pharmaceutical Organization (GPO), Thai Red Cross, and Defence Pharmaceutical Factory (DPF) all play a major role in the manufacturing and importation of orphan drugs. However, the Thai FDA has issued a request to both Thai manufacturers and importers to join in the production and importation of orphan drugs to facilitate increased supply. For more information about the orphan drugs and drug shortage issue in Thailand, you can visit the following website.

http://drugshortages.nhso.go.th/drugshortages/

 

Also from this Legal Handbook

1. Are biosimilar medicines considered the same as generic medicines in your country?

No. At present, a “biosimilar” is not the same as a generic drug. Previously, some biological marketing authorization licenses were obtained by using the same registration pathway of generic medicines (i.e., without the submission of pre-clinical or clinical studies). From a safety standpoint, the FDA has found that relying on bioequivalence studies alone is not sufficient to demonstrate the similarity of biological-derived products, due to their complexity.

 

2. Are all biologic medicines, including biosimilar medicines, patentable in your country?

Not all biologic medicines are patentable in Thailand. According to Section 9(1) of the Thai Patent Act, patentability of naturally occurring microorganisms and their components, animals, plants, or extracts from animals or plants are precluded.

Many biological products for human and animal therapies are not entirely naturally occurring, and they may involve human manipulation. Such products are likely to be patentable in the United States and the European Union. In Thailand, however, the Patent Office of the Department of Intellectual Property maintains discretion over whether a biologically derived product—especially one that may be particularly new or ground-breaking—will be considered as manmade or naturally occurring, and also over how much human manipulation is required for a product to be considered manmade. Thus, a patent for a biological product obtained from natural isolation and purification is less certain. The Thai Department of Intellectual Property is more likely to grant patents for biological inventions related to a new formulation or the modification of biological products thereof.

 

3. Is there a specific regulatory framework for the marketing authorization of biosimilar medicines in your country? If yes, what is the regulatory framework for the authorization of biosimilar medicines?

Yes. The Drug Act B.E. 2510 (1969), as amended, is the main act regarding marketing authorization for modern drugs, including biosimilars. The Notification of the Food and Drug Administration Re: Biosimilar Registration Guidelines requires applicants of biosimilar products to provide the following information:

• Administrative data i.e., labeling and package inserts, certificate of pharmaceutical product issued by the regulatory authority in the manufacturing country, GMP certificate issued by the regulatory authority in the manufacturing country, GMP clearance approval letter issued by the Thai FDA, declaration of patent or patent application status, market authorization history, etc.
• Information regarding the biological substance, its manufacturing process, and the comparative physicochemical characterization between the biosimilar and the reference biological product (e.g., molecular similarity, structural analyses, etc.);
• Non-clinical and clinical trial data of comparison studies between the biosimilar and a reference biological product; and
• A risk management plan (RMP) – The RMP can be prepared in either Thai RMP format, which is based on the Japanese format, or the EU-RMP or US-Risk Evaluation and Mitigation Strategy (REMS). 

 

4. What kind of data package is needed to obtain approval for a biosimilar drug? Is this any different to the requirements for the original Biologics drug?

MA licenses for Biosimilars are approved according to the same standards of other pharmaceuticals, wherein the three main aspects mainly considered are quality, safety, and efficacy. A biosimilar dossier must be prepared in a format using either the ASEAN Common Technical Dossier (ACTD) or the electronic CTD (eCTD), according to International Conference on Harmonization, which must further be composed of three main sections (quality, non-clinical, and clinical). In addition, biosimilarity should be established at all levels (quality, safety, and efficacy) in order to demonstrate that the biosimilar and the reference medicinal product have similar profiles.

 

5. What are the requirements for the choice of the reference comparator product?

According to the Ministry Notification of July 6, 2018, with regard to the documentation of biosimilar registration, the requirements for the reference product are as below:

• The reference biological medicinal product (RBP) must be a medicinal product authorized by the Thai FDA, on the basis of a complete dossier. Alternatively, the reference biological medical product can be one that is listed in the FDA Notification.
• A single reference biological medicinal product should be used as the comparator throughout the comparability program for the quality, safety, and efficacy studies during the development of a biosimilar in order to allow the generation of coherent data and conclusions.
• However, with the aim of facilitating the global development of biosimilars and to avoid unnecessary repetition of clinical trials, it may be possible for an applicant to compare the biosimilar in certain clinical studies and in in vivo non-clinical studies (where needed) with a reference product authorized outside Thailand that is listed in the FDA Notification. In addition, the applicant is responsible for demonstrating that there are no clinically meaningful differences between the reference product authorized outside Thailand and the reference product authorized by the Thai FDA.
• For demonstration of biosimilar comparability at the quality level, the applicant must conduct a side-by-side analysis of the reference product authorized by the Thai FDA and the biosimilar product, with samples taken from a commercial batch and site. However, combined use of a reference product authorized outside Thailand and a reference product authorized by the Thai FDA is acceptable for the development of the Quality Target Product Profile of the biosimilar product.
• If certain clinical and in vivo non-clinical studies of the development program are performed with the reference product authorized outside Thailand, the applicant should provide adequate data to justify the relevance between the three products (i.e., the proposed biosimilar, the Thai FDA authorized reference product, and the reference product authorized outside Thailand). As a scientific matter, the type of bridging data needed will always include data from analytical studies (structural) or clinical pharmacokinetics or pharmacodynamics.

 

6. Can the comparator product be sourced from another regulatory jurisdiction? If yes, what are the data needed to support this approach?

Yes, a comparator product authorized outside Thailand is acceptable (see answer to question 5 in Regulatory Pricing and Reimbursement Overview).

If certain clinical and in vivo non-clinical studies of the development program are performed with a reference product authorized outside Thailand, the applicant should provide adequate data to justify the relevance between the three products (i.e., the proposed biosimilar, the Thai FDA authorized reference product, and the reference product authorized outside Thailand. As a scientific matter, the type of bridging data needed will always include data from analytical studies (structural) or clinical pharmacokinetics or pharmacodynamics.

 

7. How are the prices of biosimilar medicines regulated? Is this any different from the requirements for the original Biologics drug?

In general, manufacturers and importers are free to set prices. Prices of pharmaceutical products, including biologics and vaccines, are regulated when they are listed on the National List of Essential Drugs (NLED), which is a list of medications prescribed by doctors in public hospitals and public health services. The prices of the drugs on this list are subject to a maximum allowable price policy. Therefore, normally, the prices of both a reference biologic product and a follow-on biologic product must be less than the maximum allowable price, if the drug has been listed in the NLED.

The Government Procurement and Supplies Management Act was implemented on August 23, 2017, and aims to ensure that the purchased items are considered value for money, maximizing the effectiveness of the procurement process with transparency and accountability. The Act has an impact on the procurement of pharmaceutical products by state organizations, which include universities and university hospitals.

 

8. What is the reimbursement policy for biosimilar medicine? Is this any different from the requirements for the original Biologic drug?

There are no differences between the reimbursement policy for biosimilars and that for original biological products. Bilosimilars can be reimbursed by the state when the drugs are listed in the NLED.

 

9. Does biosimilar competition impact the reimbursement policy of the originator reference products?

Yes. Biosimiliars do have an impact on the reimbursement policy of the originator product. Provided that the biosimilar is interchangeable with that of the reference product, the entering of a biosimilar will result in a reduction of the price of the originator reference products.

 

10. What is the legal framework for biosimilar medicines prescribing (clinical decision maker) and dispensing (pharmacy level, hospital or retail)? Is this any different to the requirements for the original Biologics drug?

Under Thai law (including policy statements), the practice of generic substitution or therapeutic substitution is not explicitly described. Nonetheless, in practice, many hospitals in Thailand have established their own policies, wherein hospital pharmacists can consider generic substitutions on a case-by-case basis using their own discretion. In such cases, the cheapest generic drugs are normally chosen for patients. If the prescribing physician has prescribed a specific brand name and has indicated that no substitution is allowed, then the pharmacist will dispense the specific brand product to the patient.

 

11. Is the system considering physician-led switching and/or pharmacy-level substitution (without involvement of the clinical decision maker)?

Currently, there are no guidelines for the substitution or interchangeability of biosimilars. The choice of prescription is dependent on the individual discretion of the physician prescribing the biological product.

 

12. What are the post-authorisation requirements (including pharmacovigilance, risk management plans, post-approval studies) for biosimilar medicines? Is this any different to the requirements for the original Biologics drug?

There are no differences in the post-authorisation requirements between original biological products and biosimilars. Both of them must undergo a mandatory Safety Monitoring Program (SMP). During the SMP, the products will be available only in hospitals. In addition, the company must report adverse drug reactions, as per the template provided by the FDA, for at least two years.

The most critical safety concern is immunogenicity. Both originator and biosimilar applicants must provide a Risk Management Plan (RMP). Risk management applies scientifically based methodologies to identify, assess, communicate and minimize risk throughout a drug’s life cycle so as to establish and maintain a favorable benefit/risk profile in patients. The RMP for biosimilars should focus on heightening pharmacovigilance measures, identifying immunogenicity risks, and providing a description of the potential safety issues that may eventuate as a result of differences in the manufacturing processes.

 

13. Are there specific policies and requirements for labelling biosimilar medicines in the event of second medical use patents? Is this any different from the requirements for the original Biologic drug?

No. There are no specific policies on this matter. Provided that there is a granted patent for the originator product (whether or not there are primary or secondary patents), the biosimilar must ensure that its product does not infringe the patent rights of the originator company. Normally, the originator will file an indication amendment with the FDA for a second medical use. The labelling of the biosimilar should ensure that it does not infringe the rights of the originator company.

 

14. Have there been any significant legal/judicial developments in relation to biosimilars in your country? (Including but not limited to IP, procurement, competition, misleading information campaign, access to reference comparator product)

Yes. The FDA announced its Notification 2018 Re: Priority Review of Pharmaceutical Products. When a marketing authorization application is submitted for a product of major public health interest, the applicant may request an accelerated or fast-track review. The FDA will then ensure that the marketing authorization decision is made within 200 days. In addition, the Notification of the Ministry of Public Health announced on July 6, 2018, prescribes updated biosimilar registration guidelines as well as specific guidelines for preparing registration application dossiers for specific types of biosimilars.

 

15. Are there proposals for reform or significant change to the legal, regulatory, procurement of biosimilars? If yes, when are they likely to come into force?

At present, there is no update of the legal regulatory framework for biosimilar products. However, it is expected that further regulations for biosimilar products will be enacted in the near future.

Also from this Legal Handbook