You are using an outdated browser and your browsing experience will not be optimal. Please update to the latest version of Microsoft Edge, Google Chrome or Mozilla Firefox. Install Microsoft Edge

July 4, 2023

Practical Law: Life Sciences Regulation in Vietnam 2023

Subscribe to Updates
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.

Related Professionals

Industries

Life Sciences

Practices

Regulatory Affairs

Location

RELATED INSIGHTS​ 

April 5, 2019
Pyihtaungsu Hluttaw Law No. 9/2019—Myanmar’s new Consumer Protection Law—was enacted on March 15, 2019, repealing the previous law and providing a clearer legal framework for the protection of consumers in Myanmar. The date of implementation is March 15, 2019, with the exception of the product label requirement, which will enter into force one year after the date of enactment.  
Read More
March 21, 2019
Since the entry into effect of the 2016 Law on Pharmacy and the subsequent Decree 54/2017/ND-CP (Decree 54), pharmaceutical companies in Vietnam were eagerly awaiting a replacement for Circular No. 44/2014/TT-BYT on drug registration (Circular 44), which was based on the now-defunct Law on Pharmacy of 2005. Finally, on November 12, 2018, Circular No. 32/2018/TT-BYT (Circular 32) was issued. This circular will take effect on September 1, 2019, and will play an important role in the pharmaceutical regulatory landscape in Vietnam.
Read More
March 1, 2019
Vietnam’s Central Party Steering Committee recently issued a strong directive ordering strict policies emphasizing improved consumer protection. Specifically, Directive No. 30/CT/TW on Strengthening Party Leadership and State Management Responsibility in Consumer Protection (Directive 30) was issued on 22 January 2019.
Read More
January 30, 2019
On December 31, 2018, the Vietnamese government promulgated Decree No. 169/2018/ND-CP (Decree 169), amending Decree No. 36/2017/ND-CP (Decree 36) on medical device management. Decree 169 took immediate effect upon its issuance. The new regulations will have a great impact on the circulation of medical devices, especially foreign products, in Vietnam. Some of the major changes are set out below.Classification of Medical Devices
Read More