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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…

Korea The Top 10 Korean pharma companies ranked by 2023 sales, as compiled in the latest Citeline Scrip Asia 100. Hanmi leads the way with USD 1.14 billion in sales, a 10 percent increase on the previous year, followed by Daewoong and Boryung. Made with Visme Infographic Maker  

Switzerland Dennis Engelke, General Manager for Switzerland and Austria at Jazz Pharmaceuticals, discusses his career trajectory and the company’s growth in these markets. He highlights Jazz’s commitment to patient access and innovation, especially following the 2021 acquisition of GW Pharmaceuticals, which has enabled the company to enter the epilepsy space. Engelke…

Mexico Rogerio Peso outlines how Viatris leverages collaborations to address critical healthcare needs in Mexico, combining its strengths with other stakeholders to improve patient outcomes. With a mission to offer high-quality, affordable medicines, Peso also points out how Viatris aligns its portfolio with the healthcare needs of Latin America, addressing gaps…

Global Aitia Bio’s Colin Hill, writing in the November 2024 issue of DIA’s Global Forum magazine outlines why “digital twins” – virtual models of patients, systems, or devices that simulate real-world data to predict outcomes, optimize treatments, and improve patient care – have the potential to reshape the entire drug development…