Regulatory primer
Vietnam tender system, briefly
Pharmaceutical procurement in Vietnam’s public hospitals is strictly regulated and conducted through formal tendering. Eligible generic drugs are categorized into five technical groups — a classification that directly dictates manufacturer bidding eligibility and shapes the final contract pricing.
The Generic Drug Groups
| Group | Eligibility | Typical bidders | Pricing dynamic |
|---|---|---|---|
| Group 1 | EU-GMP (or equivalent) lines in SRA/EMA countries; OR Originators & reference biologics | Originator brands; SRA/EMA generics (e.g. Germany, UK, Japan, US) | Premium · lowest competition |
| Group 2 | EU-GMP (or equivalent) lines in other regions; OR PIC/S-GMP lines in member countries | EU-GMP generics; PIC/S generics (e.g. South Korea, Eastern Europe) | Mid-tier · moderate competition |
| Group 3 | Any GMP line producing generics with proven bioequivalence (BE) published by the DAV | Manufacturers of BE-proven generics | Mid-tier · limited competition (BE barrier) |
| Group 4 | DAV-published GMP lines with 100% manufacturing located in Vietnam | Local Vietnamese manufacturers | Domestic-preference scoring |
| Group 5 | WHO-GMP compliant lines | WHO-GMP generic manufacturers (e.g. India, China, Bangladesh) | Lowest tier · highest competition (price-driven) |
How it affects your launch
An EU-GMP molecule can compete in Groups 1, 2, 3, and 5 (subject to criteria — Group 3 additionally requires bioequivalence data), giving it the widest reach and the strongest pricing power. An imported WHO-GMP molecule typically lands in Group 5, where volumes are large but competition is sharp and price-driven. MKT Pharma reviews your CMC and regulatory dossier, maps it to the optimal Group(s), and aligns the commercial model — pricing, contract size, and field support — before we finalize a partnership.
Tender frequency
National centralized tenders typically run on an annual cycle with mid-term adjustments, while hospital-level procurement follows individual institutional schedules. Our dedicated regulatory and tender teams actively track both calendars, strategically timing your dossier filing and bid preparation to land securely in the next available cycle for your specific Group.
The current regulatory landscape
Recent regulatory updates have reshaped the rules for market entry and public tendering. The key instruments foreign partners should track:
- Law on Pharmacy No. 105/2016/QH13 — foundational framework.
- Amendment Law No. 44/2024/QH15 — relaxed administrative protocols.
- Decree No. 163/2025/ND-CP — new distribution & price-management rules.
- Circular 08/2022/TT-BYT — base drug registration.
- Circular 12/2025/TT-BYT — simplified CPP requirements.
- Circular 35/2018/TT-BYT — GMP & foreign-site recognition.
- Circular 07/2022/TT-BYT — mandatory bioequivalence (BE) list.
- Circular 40/2025/TT-BYT — bidding Groups 1–5 classification.
- Circular 37/2024/TT-BYT — expanded health-insurance reimbursement.
Market outlook: 2025–2026
2025 marks a turning point as Vietnam’s tender market shifts toward greater transparency, strict quality-tiering, and tighter cost controls. Stabilized Ministry of Health leadership and the amended Pharmacy Law (Decree 163, Circular 12/2025) will significantly streamline market entry. Crucially, the anticipated 2026 National Reimbursement Drug List (NRDL) update is expected to unlock material volume growth for reimbursed products.
Notes
- SRA:
- Stringent Regulatory Authority
- EMA:
- European Medicines Agency
- PIC/S:
- Pharmaceutical Inspection Co-operation Scheme
- DAV:
- Drug Administration of Vietnam
- BE:
- Bioequivalence
- CMC:
- Chemistry, Manufacturing, and Controls
- CPP:
- Certificate of a Pharmaceutical Product
- NRDL:
- National Reimbursement Drug List
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.