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NMPA: Continuing to Advance Consistency Evaluation of Generic Drugs; 103 Batches of Reference Preparations Selected and Published
Li Jiangning, Director-General of the Department of Drug Regulation of the National Medical Products Administration (NMPA), stated that efforts will continue to advance the consist...
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NMPA: Continuing to Advance Consistency Evaluation of Generic Drugs; 103 Batches of Reference Preparations Selected and Published
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Li Jiangning, Director-General of the Department of Drug Regulation of the National Medical Products Administration (NMPA), stated that efforts will continue to advance the consistency evaluation of generic drugs. As of March 31, the NMPA had selected and published 103 batches of reference preparations, involving a total of 2,879 varieties. A total of 1,695 drugs have passed or are deemed to have passed the consistency evaluation, accounting for approximately two-thirds of commonly used chemical drugs in clinical practice nationwide.

Gong Xiangguang, Director-General of the Department of Drug Policy and Essential Medicines System of the National Health Commission, noted that in recent years the country has established a coordinated response system for drug shortages. The three-tier local response capacity has remained stable at above 96%. The number of shortage items requiring coordination at the national level has dropped significantly from 64 in 2021 to two in 2025, indicating a marked easing of drug shortages.

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Going forward, authorities will continue to improve the direct reporting system for drug shortage information and, together with relevant departments, enhance monitoring mechanisms. They will promote information connectivity between active pharmaceutical ingredients and finished drug products across registration, production, procurement and pricing processes to identify and mitigate potential shortage risks in advance. At the same time, efforts will be made to strengthen the dynamic management of the drug shortage list, guide local authorities in optimizing adjustment mechanisms, and improve inter-departmental coordination to enhance supply??. (ss/u)

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