Tagged with ARM

Pharma Legal Handbook 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,…

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…

Puerto Rico With lower labour costs than mainland US, but the same regulatory framework and straightforward market access, Puerto Rico has long presented a compelling value proposition for pharmaceutical manufacturing, a sector that accounts for some 30 percent of the island’s GDP.  After bouncing back from bankruptcy, devastating hurricanes and the COVID-19…

Switzerland Stefan Berg, General Manager of Pharmaplan AG, offers insight into the company’s transformative journey as it becomes part of Exyte Group, a global leader in advanced engineering. Berg discusses Pharmaplan’s growth strategies, the evolving landscape of pharmaceutical manufacturing, and the shift towards local production, particularly in Switzerland. He also highlights…

Switzerland Dr Michael Quirmbach of CordenPharma discusses the company’s ambitious goal to become one of the top five CDMOs globally, emphasizing the importance of strong scientific expertise and customer-centricity in their operations. Dr Quirmbach highlights the significance of adapting to market demands and maintaining high compliance standards while fostering strategic partnerships.…