Tagged with Pharma Legal Handbook

Pharma Legal Handbook Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? Yes, as there is an Authority “Central Directorate for Research and Health Development”, which is responsible for the registration and approvals of conducting such preclinical and clinical trials.   How are clinical trials…

Pharma Legal Handbook What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? The authorization process of marketing new drugs and any medicinal products are as follows: An application for obtaining a marketing authorization for pharmaceuticals is submitted to CAPA. The Pharmacy Law…

Pharma Legal Handbook What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The regulatory requirements for traditional and herbal products shall follow the regulations and standards: – WHO requirements and guidelines; – Good Manufacturing Practices; – Good Laboratory Practice; – Good Pharmacovigilance Practice; – Good Agricultural and Collection…

Pharma Legal Handbook What types of liability are recognized in your jurisdiction? There are two types of liabilities in Egypt, Criminal Liability, in case the product caused any injury, permanent disability injury or wrongful death due to negligence or mistake occurred in the preparation process of the medicinal product. Civil liability, in case…

Pharma Legal Handbook What are the basic requirements to obtain patent and trademark protection? In accordance to the Executive Regulations provided in the Decree No. 1366 of the year 2003, the requirements to obtain patents are as follows: Fill the application for patents at the Patent office; the patent application shall be accompanied…

Pharma Legal Handbook Are there proposals for reform or significant change to the healthcare system? No, but the Comprehensive Health Insurance Scheme Law No. 2 of year 2018 and its Executive Regulations issued by virtue of the Prime Minister’s Decree No. 909 of the year 2018.   When are they likely to come…

Pharma Legal Handbook Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? No, Cannabinoid Drugs are not authorized in Egypt, however, they are regulated by Law No. 182 of the year 1960 concerning combating drugs and regulating their use and trafficking.   2. What are the regulatory authorities with jurisdiction over Cannabinoid…

Pharma Legal Handbook Are biosimilar medicines considered the same as generic medicines in your country? In Egypt, Biosimilars are considered different from Generic Medicines but similar to biological products, where the “Biosimilar” definition according to the Guidelines for Registration of biosimilar products in Egypt, is the following: A similar biological medicinal product having…

Pharma Legal Handbook 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, the legal framework of localization is regulated through Ministerial Decree No. 296 of 2009, No. 425 of the year 2015, Ministerial Decree No. 820 of…

Pharma Legal Handbook What is the definition of Rare Diseases in your country? In Egypt, there is no definition of the “Rare Diseases” however, in accordance with the conclusion of medicine professors’ researches and studies a disease is considered a rare disease if it affects 1 in 2,000 or 2,500 individuals.   Does…

Pharma Legal Handbook   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…

Pharma Legal Handbook 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…