Regulatory primer
Vietnam tender system, briefly
Vietnam’s public-hospital pharmaceutical procurement runs through tenders divided into four Groups by manufacturer GMP credential. A molecule’s Group classification determines which manufacturers can bid — and the pricing dynamics of the resulting contract.
The four Groups
| Group | Eligibility | Typical bidders | Pricing dynamic |
|---|---|---|---|
| Group 1 | SRA-approved (EMA, FDA, PMDA, etc.) + originator or first-generic | Originator brands, SRA-approved biosimilars | Premium · lowest competition |
| Group 2 | EU-GMP, PIC/S countries; bioequivalence required | EU-GMP generics, Korean GMP generics | Mid-tier · moderate competition |
| Group 3 | Vietnam-GMP manufacturers | Local Vietnamese manufacturers | Domestic-preference scoring |
| Group 4 | WHO-GMP | India, Bangladesh, China WHO-GMP manufacturers | Price-led · highest competition |
How it affects your launch
A molecule with EU-GMP credentials can compete in Groups 1–4 (subject to other criteria), maximizing addressable volume. A WHO-GMP-only molecule is restricted to Group 4 — meaning higher volume but price-driven competition. The Group your molecule lands in shapes margin, contract size, and the commercial team that needs to support it. Vinapharma maps your dossier to the optimal Group(s) before we agree a partnership.
Tender frequency
National tenders run roughly annually with mid-cycle adjustments; hospital-level tenders run on individual institutional schedules. Our regulatory affairs team tracks both calendars and times dossier filing and bid preparation to land in the next available cycle for your Group.
The 2024–2025 regulatory backdrop
A run of circulars in 2024 reset the tender environment. The most relevant for international partners:
- Tender Circular (07/2024/TT-BYT, May 2024) — public-hospital drug tenders
- Price Negotiation Circular (05/2024/TT-BYT, May 2024)
- National Centralized Procurement drug list (04/2024/TT-BYT, April 2024)
- Domestic EU-GMP threshold circular (03/2024/TT-BYT, April 2024)
- NRDL criteria (37/2024/TT-BYT, November 2024)
- New Pharma Law (November 2024)
- MA renewal amendment (55/TT-BYT, December 2024)
2025 outlook: New Pharma Law implementation (Decree + Drug Registration regulation TT12/2025), continued MOH leadership stability following government restructuring, and an updated National Reimbursement Drug List (NRDL) anticipated for 2026.
Sources
Group structure and circulars: Vietnam MOH (Bo Y te) primary legislation, 2024 series. Market data: IQVIA MAT Q3’24, IQVIA Vietnam Oncology Landscape (March 2024). Facts here are indicative for international BD readers; specific dossier and tender strategy decisions require RA review against the live regulatory text.