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Policy Interpretation of the Implementation Measures for Drug Regulatory Data Protection
2026-10-27
The core of drug regulatory data protection lies in protecting original regulatory data generated to demonstrate the safety and efficacy. Therefore, new data protection can only be granted if new data demonstrating the safety and efficacy of the drug is generated.
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Announcement of the National Medical Products Administration on Matters Concerning Further Optimizing Review and Approval of Overseas-Marketed Drugs in Clinical Urgent Need (No. 3, 2026)
2026-10-27
In order to accelerate the marketing of overseas-marketed drugs in China in clinical urgent need and meet patients’ urgent clinical medication needs, the National Medical Products Administration (NMPA) decided to further optimize the working mechanism for review and approval of overseas-marketed drugs in clinical urgent need.
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Policy Interpretation of the Announcement of the National Medical Products Administration on Matters Concerning Further Optimizing Review and Approval of Overseas-marketed Drugs in Clinical Urgent Need
2026-10-27
In order to further encourage more overseas-marketed drugs in clinical urgent need to enter the Chinese market and benefit domestic patients, NMPA has researched and drafted the Announcement of NMPA on Matters Concerning Further Optimizing Review and Approval of Overseas-marketed Drugs in Clinical Urgent Need (hereinafter referred to as the Announcement).
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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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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").
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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.
