Vietnam Profile Updated in ClinRegs
December 15, 2020
The Vietnam profile in ClinRegs has been reviewed and updated where appropriate to reflect current regulatory requirements including:
- Circular No. 4/TT-BYT – Regulations on the Establishment, Functions, Duties, and Powers of the Ethics Committee in Biomedical Research (Vietnamese): Provides updated requirements for ethics committees at the national and institutional levels (See the Ethics Committee, Clinical Trial Lifecycle, Sponsorship, and Informed Consent topics)
- Circular No. 32/2018/TT-BYT – Regulations on Registration of Drugs and Medicinal Materials (Vietnamese): Provides information regarding circumstances under which certain drugs may be circulated with an exemption from one or more stages of a clinical trial (See the Scope of Assessment section)
- Circular No. 10/2020/TT-BYT – Regulations on Drug Bioequivalence Trials (Vietnamese): Updates have been made throughout the profile to refer to this Circular’s Appendix on good clinical practice, which has replaced Appendix I of Circular No. 29/2018/TT-BYT – Regulations for Clinical Trials on Drugs. The main difference is that this new appendix adds language regarding bioequivalence trials.