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 traditional medicines under Circular 12/2025/TT-BYT (replaced TT 08/2022 and TT 32/2018). 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). 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 full text — https://thuvienphapluat.vn/van-ban/The-thao-Y-te/Thong-tu-12-2025-TT-BYT-dang-ky-luu-hanh-thuoc-nguyen-lieu-lam-thuoc-630038.aspx
- ASEAN ACTD guidelines — https://asean.org/our-communities/economic-community/asean-cosmetic-directive/
- Last reviewed:
- 2026-06-28
- Page updated:
- 2026-06-28