Vietnam Updates Pharmaceutical Regulations for Controlled Substances
Vietnam is revising its regulations concerning controlled drugs and pharmaceutical ingredients, aiming to address practical challenges in hospital pharmacy management and align with updated legal frameworks. The Ministry of Health is currently drafting amendments to Circular 20/2017/TT-BYT, which details the Law on Pharmacy and Decree 54 on medicines and pharmaceutical raw materials subject to special control.
Key Areas of Revision
The revisions focus on four primary areas:
- Lists of Controlled Substances: Updating lists of narcotics, psychotropic substances, and drug precursors to align with Decree No. 28/2026/ND-CP, issued on January 19, 2026, which stipulates the official lists.
- Storage, Production, and Distribution: Refining regulations related to the storage, production, formulation, dispensing, utilize, disposal, delivery, transportation, and reporting of controlled substances.
- Radioactive Drug Supply: Addressing activities related to the supply of radiopharmaceuticals.
- Record Keeping: Updating requirements for records, books, and documentation related to controlled medicines and pharmaceutical raw materials.
Addressing Regulatory Updates and Deficiencies
The revisions aim to address specific deficiencies and obstacles identified in the current regulations. Key adjustments include:
- Alignment with Decree 163/2025/ND-CP: Adjusting content referencing Decree 54/2017/ND-CP to correspond with the relevant articles and clauses of Decree 163/2025/ND-CP.
- Destruction of Controlled Medicines: Amending regulations on the destruction of controlled medicines by non-commercial pharmaceutical establishments to align with the provisions of Decree 163/2025/ND-CP.
- Public Security Responsibilities: Clarifying the responsibilities of the Health Department of the Ministry of Public Security regarding the management and reporting of controlled medication use in medical centers under its authority, ensuring consistency with the Military Medical Department of the Ministry of National Defense and Decree 163/2025/ND-CP.
Commitment to Effective Implementation
Deputy Minister of Health Nguyen Tri Thuc emphasized the importance of understanding practical challenges faced by hospitals to inform policy development. The Ministry of Health’s Plan No. 341/KH-BYT, dated February 27, 2026, demonstrates a commitment to eliminating institutional obstacles and creating an effective operating environment for the health system at all levels.
The Department of Drug Administration has been directed to collaborate with the Legal Department and other relevant units to ensure the revised Circular is practical, scientifically sound, legally compliant, and feasible.