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. Vinapharma’s RA team can compress timelines by 3–6 months through pre-submission consultation and parallel CMC/clinical activities.
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 credential— 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.