Regulatory calendar
A chronological view of recent and upcoming Vietnamese regulatory milestones across pharma, cosmetic, food and medical practice. Each milestone shows the governing document, affected product kinds and a link to a Medibase deep-dive article when one exists.
National Assembly passes the Pharmacy Law amendment (amends Luật Dược 105/2016); takes effect 1 July 2025.
Automatic-extension safety net for in-flight renewals, explicit reference-dossier pathway for SRA-approved products, 3-month renewal window (down from 12), dedicated innovative-drug pathway.
Implements Law 44/2024: special-control drug classification, storage / production / distribution rules, FIE notification regime (Art. 91 §12).
Operational circular for Luật Dược Chapter IV — dossier modules, timelines, expert-council process.
Replaces Circular 35/2018/TT-BYT with an updated GMP framework aligned to PIC/S developments.
Consolidated GPP text integrated with the electronic drug-records requirement.
Vietnam deposits the instrument of accession to the 1961 Hague Apostille Convention; replaces consular legalisation for most public documents from foreign signatories — major simplification for FSC / CPP / GMP packs.
Replaces Circular 50/2018; tightens timelines and aligns with ICH expectations for first-in-human and reference-product trials.
Implementing circular for the special-control medicines regime. Etomidate and Carisoprodol reclassified as psychotropic effective immediately on signature; other provisions wait for 16 July 2026.