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July 4, 2023

Practical Law: Life Sciences Regulation in Vietnam 2023

Practical Law Company

Practitioners from Tilleke & Gibbins’ Vietnam offices contributed content for the latest edition of the Practical Law Life Sciences Global Guide. The guide provides a comparative overview, in Q&A format, of laws and regulations on pharmaceuticals, medical devices, and other life sciences products in dozens of jurisdictions around the world.

The Life Sciences Global Guide is divided into two sections: Commercialization (see more details here) and Regulation, which covers the following topics:

  • Pharmaceuticals: Laws and regulatory authorities
  • Clinical trials: Legal, regulatory, and procedural requirements
  • Manufacturing and distribution
  • Marketing: Authorization for marketing medicinal products, monitoring compliance and penalties, pharmacovigilance and other commitments, foreign marketing authorizations
  • Data privacy
  • Packaging, labeling, and tracking
  • Biological medicines
  • Medical devices: Legislation and regulatory authorities, definition and classification
  • Healthcare IT
  • Combination products and borderlines
  • Natural health products
  • Recent developments and reform proposals

Practical Law, produced by Thomson Reuters, is the world’s leading legal know-how resource for business lawyers, publishing a huge range of guides covering hundreds of jurisdictions and practice areas.

The full “Life Sciences Regulation in Vietnam” section can be found on the Practical Law website.

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July 20, 2018
Practical Law has published the 2018 edition of its Distribution and Marketing of Drugs Global Guide, a easily accessible Q&A overview of the key legal issues involved in bringing drugs to market in 29 jurisdictions worldwide. Members of the Tilleke & Gibbins life sciences team wrote the Vietnam chapter of this year’s guide.
July 20, 2018
Tilleke & Gibbins has contributed to the 2018 edition of the Distribution and Marketing of Drugs Global Guide, a Practical Law Company publication covering issues related to the distribution and marketing of drugs across 28 different jurisdictions.Providing their expertise in the guide’s Thailand chapter were Alan Adcock, partner and deputy director, Siraprapha Rungpry, consultant, and Dr. Atthachai Homhuan, regulatory affairs manager, from the Tilleke & Gibbins’ intellectual property group in Thailand. The chapter covers the following topics:
June 28, 2018
On June 19, 2018, Vietnam’s prime minister issued Directive No. 17/CT-TTg on strengthening the fight against smuggling, commercial fraud, and the production and trade of fake goods and low-quality goods for pharmaceuticals, cosmetics, and functional foods (Directive 17). Directive 17 states that, while tens of thousands of cases have been discovered and handled, the situation still needs improvement, as infringers are using more complex methods and are located not only in urban areas, but also in many remote regions.
May 25, 2018
The Medical Facility Act B.E. 2541 (1998) (also known as the Sanatorium Act) was recently amended by the Medical Facility Act (No. 4) B.E. 2559 (2016) which introduced a number of changes to Thailand’s regulation of private medical facilities, e.g. private clinics and hospitals, including those performing plastic surgery. Some of the most notable changes lie in the amended Section 38, which concerns advertisements. Previously, an advertisement for a medical facility was regulated post-publication and did not require any prior approval.