Tagged with Vietnam

Pharma Legal Handbook What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? In Vietnam, pharmaceutical products (including drugs and biologicals) and medical devices are under the overall management of the Ministry of Health (www.moh.gov.vn). The Ministry of Health (“MOH”) is organized into a number of divisions,…

Pharma Legal Handbook Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? By law, clinical research documentation for the purpose of obtaining the drug MA must conform to the guidance of the International Council for Harmonization (ICH), the MOH, the European Medicines Agency (EMA) or…

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? Pharmaceutical products Under Vietnamese law, pharmaceutical products or drugs are defined to cover all modern drugs, herbal drugs, traditional drugs, vaccines, and biologicals. In general, a pharmaceutical product circulating on…

Pharma Legal Handbook What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The Law on Pharmacy and its implementing regulations are equally applicable to modern drugs and traditional and herbal drugs. There is no notion of alternative devices in Vietnamese law and therefore the legal framework for devices…

Pharma Legal Handbook What types of liability are recognized in your jurisdiction? The following types of liability are recognized under Vietnamese laws: disciplinary liability, administrative liability, civil liability and criminal liability.   How do these types of liabilities apply to the manufacturers of medicines and devices? Provisions on product liability can be found…

Pharma Legal Handbook 1. What are the basic requirements to obtain patent and trademark protection? PATENT To qualify for patent protection, an invention must meet the following basic conditions: Be globally novel; Involve an inventive step; and Have its subject matter capable of industrial application. TRADEMARK To be eligible for protection as a…

Pharma Legal Handbook 1. Are there proposals for reform or significant change to the healthcare system? Law on Medical Examination and Treatment The draft version of an amended Law on Medical Examination and Treatment was submitted to the National Assembly in May 2022 for discussion. Once adopted, the new law will repeal the…

Pharma Legal Handbook   What is the definition of Rare Diseases in your country? There are no legal documents in Vietnam providing a definition of “rare diseases.”   Does the designation of ‘Orphan Drug’ exist in your country? (Does it correspond with the definition of Rare Diseases?) An orphan drug is a drug…

ASEAN A roundup of some of the most important recent pharma news from the dynamic ASEAN region, including a big new investment from Novartis in its antibody plant in Singapore, the establishment of ‘pharmaceutical ecozones’ to streamline the drug application process in the Philippines; Vietnam’s journey to attaining WHO Level Four…

Vietnam As geopolitical tensions between China and the US increase and pharma industry stakeholders are increasingly looking elsewhere in Asia to diversify their supply chains, Vietnam has emerged as a highly promising investment destination with a great deal of potential still to unlock. While government healthcare approaches have led the country…

Vietnam Despite a decline in pharmaceutical sales during the COVID-19 pandemic, Vietnam is among the 17 countries with the most rapidly growing pharmaceutical industries in the world, as reported by nganhduoc.vn in its 2022 pharma industry forecast. With a market value of some USD 10 billion in 2020, according to another…

Vietnam A roundup of recent pharma and healthcare news from Vietnam including Gilead’s viral hepatitis initiative, the country’s explosion of dengue fever cases and the investigation into Boston Scientific’s Vietnam operations.   Gilead initiative to improve viral hepatitis management in Vietnam and the Philippines (BioSpectrum Asia) Gilead Sciences has embarked on…