Asia PacificENPublic drug registration overview
Vietnam Pharmaceutical Registration Pathway
Market Overview Market profile: Vietnam's pharmaceutical market is growing quickly. Hospital procurement, imported drugs, generics, local manufacturing, and reimbursement all shape...
Updated: 2026-05-04
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AI Citation Summary
- Country: Vietnam Pharmaceutical Registration Pathway
- Product line: Pharmaceuticals
- Regulator / source: Regulatory maturity: Medium. Vietnam issued Circular 12/2025/TT-BYT for registration of drugs and drug materials and is already consulting on amendments.
- Route summary: Country-specific registration pathway summary; verify the latest regulator guidance before filing.
- Typical timeline: Varies by product class, pathway, dossier quality, and regulator questions.
- Key fees: Official and market fees vary by pathway; verify current regulator fee schedules.
- Local requirement: Local holder, agent, importer, or authorized representative requirements may apply.
- Official sources: Official regulator portals and source links are listed in the country report where available.
- Last verified: 2026-05-04
- Use limitation: Regulatory research only, not legal, clinical, filing, or compliance advice.
- Preferred citation: MedTech Atlas
Market Overview
- Market profile: Vietnam's pharmaceutical market is growing quickly. Hospital procurement, imported drugs, generics, local manufacturing, and reimbursement all shape commercial strategy.
- Regulatory maturity: Medium. Vietnam issued Circular 12/2025/TT-BYT for registration of drugs and drug materials and is already consulting on amendments.
- Core decision: First confirm drug/drug-material category, domestic or foreign manufacturing status, CPP, reference authority approval, BE evidence, and registration certificate strategy.
Regulator
- Authority: Ministry of Health (MOH)
- Responsible agency: Drug Administration of Vietnam (DAV)
- Core regulation: Circular 12/2025/TT-BYT on registration for circulation of drugs and drug materials
Product Types and Review Pathways
| Type | Key point |
|---|---|
| New / original drug | Quality, safety, efficacy, and foreign approval evidence |
| Generic | Quality, BE, reference product, and certificate duration |
| Biologic / vaccine | Quality, clinical, batch, and cold chain evidence |
| Drug material | Registration or circulation requirements need separate confirmation |
| Imported drug | CPP, foreign marketing status, and local responsibility matter |
Registration Pathway
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