Pharmaceutical Compliance
Regulatory Update: Circular No. 30/2025/TT-BYT on Quality Standards, Testing, and Recall of Drugs
Guiding the Application of Drug Quality Standards (Dược Chất, Vắc Xin), Inspection Procedures, and Handling Mechanisms for Non-Compliant Drugs.
Circular No. 30/2025/TT-BYT, issued by the Ministry of Health on July 01, 2025, provides detailed instructions for applying quality standards, testing, and managing the recall and disposal of non-compliant drugs and raw materials. Ban hành dựa trên Luật Dược và Nghị định 163/2025/NĐ-CP, Thông tư này nhằm đảm bảo chất lượng và an toàn của các sản phẩm dược phẩm lưu hành trên thị trường, đồng thời chuẩn hóa quy trình xử lý các vi phạm.
Key Highlights
- Scope of Application: The Circular guides the detailed application of quality standards for drugs (chemical, herbal, vaccines, bio-products) and raw materials (trừ dược liệu và bán thành phẩm dược liệu), procedures for drug testing, and the process for recalling and handling defective drugs and raw materials.
- Key Updates/Content:
- Quality Standards: Specifies the hierarchy and application of quality standards, prioritizing the Vietnamese Pharmacopoeia (Dược điển Việt Nam) or recognized foreign pharmacopoeia, or registered manufacturing standards.
- Drug Inspection and Testing: Outlines the role and responsibilities of state drug testing agencies in conducting quality inspections and testing of drugs and raw materials, especially for imported batches.
- Drug Recall (Thu Hồi): Details the levels of compulsory recall (mức độ thu hồi) and the responsibilities of registration holders, manufacturers, and distributors in executing a recall, as well as the reporting requirements to competent authorities.
- Handling Violations: Provides guidance on the destruction and disposal of non-compliant drugs, including specific financial responsibilities (e.g., refunding sampling fees/testing costs for non-compliant samples).
This summary is provided for reference purposes only and highlights key aspects of Circular No. 30/2025/TT-BYT. For full and legally binding content, please refer strictly to the attached official document.
Attached File:
📎 Circular No. 30/2025/TT-BYT (Official PDF – signed & sealed)
