Regulatory tool
DAV dossier timeline
Vietnam’s Drug Administration (DAV) registration timelines vary with dossier type, manufacturer GMP credential, and whether the molecule is approved in a reference market. Adjust the inputs below to see an indicative range.
Estimate your DAV registration timeline
Adjust the three inputs below to see an indicative timeline.
Indicative only. MKT Pharma’s RA team can compress timelines by 3–6 months through pre-submission consultation and parallel CMC/clinical activities. Timeline covers complete dossier submission through marketing authorization (including supplementation rounds); excludes clinical/preclinical study execution. Based on Circular 12/2025/TT-BYT, effective July 1, 2025.
How we shorten the path
Pre-submission consultations with DAV reviewers, parallel CMC and clinical packaging work, and early commitment to the optimal Group filing typically save 3–6 months over the indicative timeline above. Our regulatory affairs team handles every step — from dossier construction through query response and the final marketing authorization grant.
What drives the math
- Dossier type— new chemical entities and biosimilars carry the largest baseline review burden; generics with bioequivalence data move fastest.
- GMP credentials — SRA-paired EU-GMP receives the lightest scrutiny; WHO-GMP adds review depth.
- Reference market — an existing EU/US registration or ASEAN reference shortens DAV evaluation; molecules without a reference market face the longest path.
Key terms explained
- SRA — Stringent Regulatory Authority
- US FDA, European Medicines Agency (EMA), Japan’s PMDA, Australia’s TGA, or Health Canada. GMP from SRA-inspected facilities translates into faster DAV approval.
- CPP — Certificate of Pharmaceutical Product
- One CPP required under Circular 12/2025 (simplified from prior rules). Must come from the manufacturing country’s authority or an EMA/SRA member country.
- ACTD — ASEAN Common Technical Dossier
- Standardized format for drug registration across ASEAN. Vietnam aligns with ICH/ASEAN standards.
⚠ Important notice
This timeline is indicative only and based on Circular 12/2025/TT-BYT (effective July 1, 2025). Actual registration timelines may vary based on:
- Dossier completeness (initial 10–15 working-day check)
- DAV workload and review priority
- Number and complexity of supplementation rounds (up to 2 rounds, 6 months each)
- Responses to deficiency queries
The estimate represents the official DAV review window AFTER a complete dossier is formally accepted. Pre-submission consultation and dossier preparation typically require 3–6 additional months. For project-specific timelines, contact MKT Pharma’s Regulatory Affairs team.