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.
| Effective date | Document ID | Name | Affected kinds |
|---|---|---|---|
| 2026-09-11 | Hague Apostille Convention 1961 | Hague Apostille Convention in force for Vietnam | drug, medical_device, treaty |
| 2026-10-01 | Thông tư 32/2026/TT-BYT | Circular 32/2026/TT-BYT — new drug-registration framework in force | drug |
| 2027-01-01 | Hội đồng Y khoa Quốc gia | National Medical Licensing Examination operational | practice |
| 2027-07-01 | TT 32/2025/TT-BYT | Traditional-medicine licensing fully delegated to provinces | drug |
| 2032-01-01 | Luật 15/2023/QH15 | Vietnamese-language requirement hardens for foreign practitioners | practice |
Apostille replaces consular legalisation for public documents from other signatories — direct simplification for FSC / CPP / GMP and medical-device technical files.
Replaces Circular 12/2025/TT-BYT as the operational rulebook for marketing authorisation of chemical drugs, vaccines, biologicals, herbal medicines, and pharmaceutical starting materials. Traditional medicine (thuốc cổ truyền) continues under Circular 29/2025/TT-BYT — not in scope of 32/2026. Transitional provisions for in-flight dossiers filed before 1 October 2026 expected in DAV implementation guidance.
The NMLE under the Hội đồng Y khoa Quốc gia becomes the mandatory route for new CCHN KCB issuance for doctors. Exact rollout date phased under Law 15/2023 framework — confirm against MOH announcements.
End of the 12-month transition (from 1 July 2026) — registration of vị thuốc cổ truyền and dược liệu is fully handled at the provincial Sở Y tế.
End of the deferred transition: foreign healthcare practitioners must satisfy the Vietnamese-language proficiency requirement to maintain CCHN KCB.
