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Implementation Opinions on "Artificial Intelligence + Drug Regulation" issued by NMPA
2026-08-20
The issuance of the Opinions is an important measure by the NMPA to implement the decisions and plans of the Party Central Committee and the State Council on comprehensively deepening reform and advancing the "AI +" initiative. It will effectively promote the innovative application of AI in the whole lifecycle regulation of "drugs, medical devices, and cosmetics," injecting strong impetus into safeguarding public medication safety and promoting the high-quality development of the pharmaceutical industry.
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Implementation Opinions of NMPA on "Artificial Intelligence + Drug Regulation"
2026-08-20
To implement the Opinions of the State Council on In-depth Implementation of the "Artificial Intelligence +" Initiative and the Opinions of the General Office of the State Council on Comprehensively Deepening the Reform of Regulation of Drugs and Medical Devices to Promote the High-Quality Development of the Pharmaceutical Industry, seize the major strategic opportunity presented by the development of AI, promote the in-depth integration of AI with drug regulation, and accelerate the modernization of drug regulation, the following opinions are hereby formulated as follows.
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Policy Interpretation of the Implementation Opinions of the NMPA on "Artificial Intelligence + Drug Regulation"
2026-08-20
In order to thoroughly implement the Opinions of the State Council on Further Implementing the "Artificial Intelligence +" Initiative and the Opinions of the General Office of the State Council on Comprehensively Deepening the Regulatory Reform of Drugs and Medical Devices to Promote the High-Quality Development of the Pharmaceutical Industry, and to seize major strategic opportunities presented by the development of AI, the National Medical Products Administration (NMPA) has issued the Implementation Opinions of NMPA on "Artificial Intelligence + Drug Regulation" (hereinafter referred to as the Opinions). An interpretation of the relevant content is hereby provided as follows.
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Announcement of the National Medical Products Administration on Strengthening Supervision and Administration of Contract Manufacturing of Drugs (No. 134, 2025)
2026-04-14
In order to further strengthen supervision and administration of contract manufacturing of marketed drugs, clarify the obligations and responsibilities of all parties, and urge the marketing authorization holders (hereinafter referred to as MAHs) for marketed drugs under contract manufacturing and contract manufacturers to jointly fulfill the main responsibility of ensuring drug quality and safety, the relevant matters concerning strengthening supervision and administration of drug contract manufacturing are hereby announced in accordance with the Drug Administration Law of the People's Republic of China and the Provisions for the Supervision and Administration of Drug Manufacturing.
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Announcement of the National Medical Products Administration on Issuing the Administrative Provisions on Inspection and Export Certificate for Pharmaceutical Products Exported by Pharmaceutical Manufacturers([2025] No. 113)
2025-12-24
In order to support the export trade of pharmaceutical products and strengthen the management of inspection and export certificate for exported pharmaceutical products of pharmaceutical manufacturers, the National Medical Products Administration has formulated the Administrative Provisions on Inspection and Export Certificate for Pharmaceutical Products Exported by Pharmaceutical Manufacturers, which is hereby promulgated and shall come into force as of January 1, 2026.
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Policy Interpretation of the National Medical Products Administration on Issuing the Administrative Provisions on Inspection and Export Certificate for Pharmaceutical Products Exported by Pharmaceutical Manufacturers
2025-12-24
In order to implement the spirit of "Supporting the Export Trade of Drugs and Medical Devices" outlined in the Opinions of the General Office of the State Council on Comprehensively Deepening the Reform of the Regulation of Drugs and Medical Devices to Promote the High-Quality Development of the Pharmaceutical Industry (GBF [2024] No. 53), the National Medical Products Administration (NMPA) has formulated the Administrative Provisions on Inspection and Export Certificate for Pharmaceutical Products Exported by Pharmaceutical Manufacturers, (hereinafter referred to as the "Provisions").