Drug companies

Vietnam follows ACTD / ICH CTD format under Circular 31/2025/TT-BYT (in force 2025-07-01), with five modules:

• Module 1 — administrative & prescribing information (country-specific).
• Module 2 — overviews and summaries (CTD).
• Module 3 — quality (chemistry, manufacturing, controls).
• Module 4 — non-clinical study reports.
• Module 5 — clinical study reports.

Submission is online via dichvucong.dav.gov.vn. Generics use a slimmed Module 4/5 with the bioequivalence study replacing most reports. Statutory timelines: 12 months (new drug), 9 months (generic), 6 months (renewal). Real timelines have been longer but should normalise under the post-2025 framework.

Two regimes apply depending on when your MA was issued:

• MAs issued ≥ 2025-07-01 (Law 44/2024 era): renewal dossier filed at least 3 months before expiry triggers automatic extension while DAV reviews. Statutory processing time: 6 months.
• MAs issued < 2025-07-01 (Circular 08/2022 era): renewal must be filed at least 12 months before expiry. No automatic safety net — late filing means the MA lapses on expiry date.

After the first renewal under the new law, subsequent renewals fall under the 3-month rule. Use the Expiry & Renewal Calculator at /tools/?tab=expiry for date math.

Automatic extension is the Law 44/2024 mechanism that prevents an MA from lapsing while DAV is still reviewing a timely renewal application. It applies when:

• Your MA was issued on or after 2025-07-01 OR has already been renewed once under the new law.
• You filed a complete renewal dossier at least 3 months before expiry.
• The dossier passed administrative-completeness review.

During the extension, the MA stays in force at the original conditions — you can continue importing, manufacturing, and distributing without interruption. The mechanism was added in response to the 2022–2024 backlog crisis, where many products lost market authorisation while waiting for renewal decisions.

Law 44/2024 introduced an explicit reference-dossier pathway for products already approved by a Stringent Regulatory Authority (SRA) — US FDA, EMA, PMDA (Japan), MHRA (UK), Health Canada, TGA (Australia), Swissmedic.

• Reduced quality / non-clinical / clinical evaluation: DAV can rely on the SRA review.
• Target processing time of 6–9 months for SRA-recognised products.
• Submission still requires Vietnam-specific Module 1 (labelling, prescribing information in Vietnamese, local representative information).
• Bioequivalence to a Vietnamese reference may still be requested for generics.

This is the single biggest practical speed-up under the new framework, and matches the parallel trend toward reliance pathways at other ASEAN regulators.

Circular 28/2025/TT-BYT (in force 2025-07-01) replaces TT 35/2018 with an updated GMP framework aligned to PIC/S developments. Key shifts:

• Refreshed Annexes on sterile, biological, and ATMP manufacturing.
• Risk-based quality system: PQR, change control, and CAPA expectations.
• Pharmaceutical quality system (ICH Q10) explicitly required for all manufacturers.
• Cross-contamination control reinforced with toxicological assessment.
• Annual product quality review mandatory.

WHO-GMP certificates issued before 2025-07-01 remain recognised until expiry, but new certifications and re-inspections use the TT 28/2025 framework. EU-GMP and PIC/S-GMP recognition follows the dosage-form-specific rule under TT 40/2025/TT-BYT.

Marketing authorisation holders carry the primary pharmacovigilance obligation under Circular 07/2018/TT-BYT (with updates pending under the post-Law 44/2024 framework):

• Maintain a Vietnam-resident contact point and a quality-management system for safety reports.
• Submit Individual Case Safety Reports (ICSRs) to the National Drug Information & Adverse Drug Reaction Monitoring Centre (DI&ADR Centre / Trung tâm DI & ADR Quốc gia).
• Serious unexpected ADRs within 15 days; non-serious within periodic reporting cycle.
• Periodic Safety Update Reports (PSURs) per the harmonised ICH schedule.
• Risk Management Plan (RMP) for high-risk products.

Failure to comply can trigger MA suspension and is among the most-cited findings in DAV post-market inspections.