ASEAN Common Technical Dossier (ACTD)
ASEAN ACTD — Common Technical Dossier for Drug Registration
- EN
- ASEAN ACTD — Common Technical Dossier for Drug Registration
- VI
- Mẫu hồ sơ ACTD — Hồ sơ kỹ thuật chung ASEAN cho đăng ký thuốc
- JA
- ASEAN ACTD — 医薬品登録共通技術ドシエ
Medicine
https://dichvucong.dav.gov.vn
Description
The ASEAN Common Technical Dossier (ACTD) is the regional dossier format used across ASEAN member states for drug registration. Vietnam accepts ACTD submissions for new chemical entities, generics, biologicals, vaccines and herbal drugs under Circular 12/2025/TT-BYT (replaced TT 08/2022 and TT 32/2018); traditional medicines register separately under Circular 29/2025/TT-BYT. From 1 October 2026, Circular 32/2026/TT-BYT replaces Circular 12/2025 as the operating framework (traditional medicine stays under Circular 29/2025). The ICH CTD format is also accepted for products with SRA approvals.
Legal basis
Circular 12/2025/TT-BYT — drug-registration framework (effective 1 July 2025). To be replaced by Circular 32/2026/TT-BYT from 1 October 2026 — see /regulations/#tt-32-2026 and /news/thong-tu-32-2026-tt-byt-dang-ky-luu-hanh-thuoc/ Pharmacy Law 105/2016/QH13 + Law 44/2024/QH15.
- Issuing authority
- Drug Administration of Vietnam (DAV), MOH
- Format
- PDF + Word
- Submission
- Online via dichvucong.dav.gov.vn
Additional links
- TT 12/2025/TT-BYT — https://datafiles.chinhphu.vn/cpp/files/vbpq/2025/5/12-byt.pdf
- TT 32/2026/TT-BYT (effective 01/10/2026) — see /regulations/#tt-32-2026
- ASEAN ACTD guidelines — https://asean.org/our-communities/economic-community/asean-cosmetic-directive/
- Last reviewed:
- 2026-06-28
- Page updated:
- 2026-08-16