Regulatory Update: Circular No. 28/2025/TT-BYT on Procedures for Drug Registration (Marketing Authorization)
Detailing Dossier Requirements, Submission Procedures, Timelines, and Conditions for Issuance, Renewal, and Revocation of Drug Registration Certificates.
Circular No. 28/2025/TT-BYT, issued by the Ministry of Health on July 10, 2025, sets forth comprehensive regulations concerning the dossiers and procedures for applying for, re-issuing, renewing, modifying, supplementing, and revoking Drug Registration Certificates (Giấy đăng ký lưu hành thuốc). This Circular is essential for pharmaceutical manufacturers and importers, providing the legal framework for bringing new and existing drugs and medicinal raw materials into the Vietnamese market.
Key Highlights
- Scope of Application: The Circular applies to domestic and foreign organizations and individuals involved in the filing and application processes related to the registration of drugs (finished products) and raw materials for medicine production (nguyên liệu làm thuốc) in Vietnam.
- Key Updates/Content:
- Dossier Structure: Specifies the detailed required documentation (Hồ sơ) for initial applications, renewals, and modifications, often based on the Common Technical Document (CTD) or ASEAN Common Technical Dossier (ACTD) format.
- Review Procedures & Timeline: Outlines the sequence of application review, expert consultation, and approval process, along with specific timeframes for competent agencies (Bộ Y tế/Cục Quản lý Dược) to process and respond to applications.
- Changes and Supplements: Clarifies the categorization of changes (major/minor) to a registered drug and the corresponding application requirements for approval (thay đổi, bổ sung).
- Renewal and Revocation: Details the necessary steps and supporting documents required for renewing an expiring registration and the grounds for compulsory or voluntary revocation of a registration certificate.
This summary is provided for reference purposes only and highlights key aspects of Circular No. 28/2025/TT-BYT. For full and legally binding content, please refer strictly to the attached official document.
Attached File:
📎 Circular No. 28/2025/TT-BYT (Official PDF – signed & sealed)
