New legal framework for pharmaceutical quality control The Ministry of Health has recently approved Decision 3960/QĐ-BYT, officially introducing the Vietnamese Pharmacopoeia VI (VP VI). This comprehensive technical compendium establishes mandatory criteria for the quality assessment, analysis, and standardization of all drugs, raw materials, and biological products within the national market.
Detailed breakdown of 1,722 technical standards The updated pharmacopoeia encompasses an extensive range of monographs, reflecting the complexity of modern pharmaceutical science:
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Chemical Medicines: 553 standards for active pharmaceutical ingredients (APIs) and 458 for finished dosage forms.
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Traditional Medicine: 417 monographs dedicated to herbal substances and traditional remedies.
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Biological Products: 51 standards for vaccines, antisera, and medical biologicals.
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Ancillary Standards: 11 protocols for primary packaging materials and 232 general testing methods.
Implementation timeline and enforcement The VP VI is scheduled to take full legal effect on July 1, 2026. Following this date, all pharmaceutical quality inspections, evaluations, and registrations must strictly adhere to these updated specifications. The Drug Administration of Vietnam (DAV), along with relevant specialized agencies, will oversee the systematic implementation and enforcement of these standards across the entire healthcare and manufacturing sector.