Clinical trial / BE application
Clinical Trial Application (TT 50/2025/TT-BYT)
- EN
- Clinical Trial Application (TT 50/2025/TT-BYT)
- VI
- Hồ sơ đề nghị thử thuốc trên lâm sàng (TT 50/2025/TT-BYT)
- JA
- 臨床試験申請（TT 50/2025/TT-BYT）
Medicine
https://asttmoh.vn
Description
Two-stage application: trial-registration dossier (Form 6 + IB summary) and study-approval dossier (full IB, protocol with Form 8, CRF, investigator CVs and GCP certificates, ICF, ethics committee approval, IP labelling). Submitted to ASTT under Circular 50/2025/TT-BYT (effective 27 February 2026; replaces TT 29/2018).
Legal basis
Pharmacy Law 105/2016/QH13 Chương XI Articles 86–94. Decree 163/2025/NĐ-CP Article 23. Circular 50/2025/TT-BYT.
- Issuing authority
- Cục Khoa học công nghệ và Đào tạo (ASTT)
- Format
- Other / multiple
- Last reviewed:
- 2026-06-28
- Page updated:
- 2026-06-28