Vietnam Regulatory Watch: Drug Regulatory Reforms and E-Commerce Expansion – August 2025
Welcome to our August 2025 Vietnam Health Regulatory Update. This month, we spotlight three key regulatory developments that are shaping the pharmaceutical landscape in Vietnam. These changes may offer both compliance challenges and strategic opportunities for Japanese pharmaceutical companies.
1. New Circular 30/2025: Drug Quality Standards and Recall Procedures
Effective July 1, 2025, Circular No. 30/2025/TT-BYT replaces Circular 11/2018, bringing comprehensive updates to drug quality assurance and recall protocols.
Key updates include:
- Recognition of Japanese Pharmacopoeia (JP): Companies may now use JP alongside other international pharmacopoeias (USP, EP, BP), providing enhanced flexibility in dossier preparation and product testing.
- Electronic recall notification system: Mandatory reporting of substandard products through a centralized platform, with clearer timelines and responsibilities.。
- Simplified processes for non-critical recalls, reducing disruption and improving risk-based management.
Official Source (Vietnamese): Government Portal – Circular 30/2025/TT-BYT on Drug Quality and Recall
2. Decree 163/2025 & Circular 31/2025: E-Commerce and Controlled Substances
These new provisions mark a significant shift in pharmaceutical distribution and compliance:
- Legalization of pharmaceutical e-commerce: Online platforms can now sell drugs legally if they publicly display valid business licenses and pharmacy professional certifications.
- Simplified destruction of controlled substances: Narcotics and psychotropics can now be destroyed with a 7-day advance notice, removing the need for prior MOH approval and easing operational burdens.
This opens up new commercial channels while requiring strict documentation transparency.
- Official Source (Vietnamese): Government Portal – Decree 163/2025/ND-CP on Pharmaceutical E-commerce and Controlled Substance Disposal
- Official Source (Vietnamese): Government Portal – Circular 31/2025/TT-BYT Detailed Guidelines on Implementation of the Law on Pharmacy and Decree 163/2025/ND-CP
3. Amended Law on Pharmacy (Law 44/2024): Investment Incentives and Streamlined Registration
The amended Pharmacy Law introduces major reforms aimed at attracting investment and accelerating drug market access:
- Pharma R&D and manufacturing designated as “priority sectors,” enabling access to tax incentives and land-use privileges for qualifying projects (≥ VND 3,000 billion / ~JPY 15 billion).
- Shortened registration timelines: Supplementation is now limited to two rounds, with a third only in exceptional cases.
- Simplified renewal applications if product quality has remained stable over the license term.
These changes aim to improve regulatory predictability for foreign manufacturers.
Official Source (Vietnamese): Government Portal – Law 44/2024/QH15 Amending the Law on Pharmacy
We hope this update provides valuable insights into the evolving regulatory landscape in Vietnam. Should you require further details or assistance in navigating these changes, please do not hesitate to contact us.
