On May 16, 2025, Vietnam Ministry of Health issued the Circular No. 12/2025/TT-BYT which will take effect from July 1, 2025. This is a crucial legal document detailing the registration of drugs and medicinal ingredients for circulation in Vietnam and replaces previous regulations, notably Circular 32/2018/TT-BYT. The new Circular is intended to harmonize with the amended Law on Pharmacy 2024 and international standards.
Key Highlights of Circular:
- Exclusion of traditional medicine and herbal drug registration from its scope, allowing for more specialized management.
- Introduction of five specific criteria for classifying over-the-counter (OTC) drugs, ensuring safety and timely access for the public.
- Clinical trial exemption regulations are more detailed, especially regarding the requirement for Asian ethnicity factor data, accelerating new drug market entry.
- Pharmacovigilance responsibilities are enhanced with detailed periodic and individual reports.
- The validity period of registration certificates is differentiated into 3 and 5 years depending on the drug type, reflecting risk levels.
- Responsibilities of registration, manufacturing, contract manufacturing, and technology transfer facilities are expanded and detailed.
- The appraisal process is also streamlined with expedited and simplified procedures, along with limits on dossier supplementation, improving administrative efficiency.
These changes offer significant benefits in enhancing drug safety, optimizing processes, and fostering international integration of the pharmaceutical industry. Businesses should note the need to review internal procedures, invest in pharmacovigilance systems, and update contracts to ensure effective compliance.
For more details, you may access the full circular from the following link:
https://vanban.chinhphu.vn/?pageid=27160&docid=213708