The Ministry of Health is finalizing a draft to amend Circular No. 12/2025/TT-BYT, aimed at optimizing the licensing process for drugs and medicinal ingredients. The primary focus is on streamlining administrative procedures, enhancing IT application, and aligning technical standards with international benchmarks.
Key adjustments in the draft This draft proposes modifying approximately 41% of the original content (23 out of 56 articles), focusing on the following technical and legal groups:
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International standard referencing: Recognizing the Certificate of Suitability to the monographs of the European Pharmacopoeia (CPP) and standards approved by the European Directorate for the Quality of Medicines (EDQM). Manufacturer verification will be conducted directly through EDQM’s public electronic database.
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Exemption mechanisms: Proposing exemptions for clinical records for non-new drugs or active ingredients that have similar products already licensed in Vietnam, particularly those authorized in the European market.
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Technical and technological aspects: Adjusting regulations on stability data for technology-transfer drugs; classifying shelf-life standards based on the actual characteristics of vaccines, biologicals, and pharmaceuticals.
Modern management orientation Deputy Minister of Health Nguyen Tri Thức emphasized that the amendments are not merely procedural changes but the creation of a “smart technical barrier.” Notable highlights include:
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Digital transformation: Promoting comprehensive online dossier appraisal solutions, covering everything from manufacturing processes to clinical data.
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Transparency and post-audit: Improving system data retrieval capabilities to facilitate post-licensing audits while making it easier for businesses to submit documents.
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Legal compliance: Ensuring that new appendices and regulations align with the Law on Pharmacy and Decree 63/N/D-CP, while staying close to the practicalities of hospital pharmacy operations.
Following the meeting, the Drug Administration of Vietnam has been tasked with further synthesizing feedback to complete the dossier and preparing unified implementation guidelines once the new Circular is officially issued.