Vietnam Regulatory Watch: Administrative Procedures, BE List Update, and Implementation Guidance – September 2025
Welcome to the September 2025 edition. This month we focus on three developments that affect regulatory operations, dossier planning, and compliance across Vietnam’s drug market.
1. MOH Decision 2546/QĐ-BYT (11 Aug 2025) — Administrative procedures consolidated
MOH announced newly issued/updated administrative procedures for the pharmaceutical domain. This aligns procedures with the 2025 pharmacy framework (e.g., Decree 163/2025 and Circular 31/2025) and gives provincial DOHs and DAV a common basis to organize implementation and public guidance.
Suggested actions:
- Refresh internal SOPs and e-dossier checklists; map new forms/flows to your agents and MA holders.
- Verify which submissions must move fully online vs. hybrid; clarify routing and receipt rules with DOHs.
- Prepare a one-page explainer for commercial teams on what information must be disclosed online.
Official Source (Vietnamese): DAV news (MOH Decision 2546)
2.DAV Decision 409/QĐ-QLD (20 Aug 2025), DAV Decision 417/QĐ-QLD (28 Aug 2025) – Bioequivalence (BE) recognition list updated (Batch 9 and Batch 10)
DAV added medicines with BE evidence. The consolidated lists support registration strategies where BE data can be leveraged for abridged reviews or comparator alignment. Sponsors should audit in-flight dossiers and comparator choices against the latest batches.
Suggested actions:
- Re-check BE-based routes and reference products; document any bridging rationale.
- Update country files and Module 1 summaries to reference the latest BE batches where applicable.
- For pipeline assets, build a matrix that maps molecules to available BE evidence/comparators.
Official Source (Vietnamese): DAV notice – BE List Batch 9, DAV notice – BE List Batch 10, DAV – Drug registration page
3. DAV Official Letter 2357/QLD-KD (15 Aug 2025) – Implementation guidance under the new pharmacy framework
This letter to provincial DOHs clarifies implementation of administrative procedures under recent regulations – responsibilities, document hygiene, and consistent handling of applications. Multiple provincial portals have reposted the letter and attachments, indicating roll-out momentum.
Suggested actions:
- Engage local DOHs to confirm cut-over dates, submission modes, and any local checklists.
- Run an internal readiness check (roles/RACI and Q&A) for affiliates/agents handling filings.
- Create a tracker for clarifications issued by DOHs and DAV to keep teams aligned.
Official Source (Vietnamese): LuatVietnam
4. Ongoing quality & safety monitoring (late Aug)
DAV continues to publish quality/recall notices. Maintain batch-level surveillance with distributors and ensure recall SOPs align with Circular 30/2025.
Links:
- Foreign companies with quality-violating drugs (Batch 41): https://dav.gov.vn/cong-van-so-2325qld-cl-ve-viec-cong-bo-dot-41-danh-sach-cac-cong-ty-nuoc-ngoai-co-thuoc-vi-pham-chat-luong-n4984.html
- Recall notices index: https://dav.gov.vn/cong-van-thu-hoi-thuoc-cn89.html
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.
