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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.
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NMPA Announcement on Matters Concerning the Importation of Pre-approval Commercial-Scale Batch Products of Overseas-Marketed Drugs (No. 96, 2025)
2025-11-28
To implement the relevant requirements of 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 (GBF [2024] No. 53), and to support the early use of innovative and clinically urgently needed drugs for the benefit of patients, the relevant matters related to the importation of pre-approval commercial-scale batches of overseas-marketed drugs are hereby announced as follows.
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Policy Interpretation of the NMPA Announcement on Matters Concerning the Importation of Pre-Approval Commercial-Scale Batch Products of Overseas-Marketed Drugs
2025-11-28
The NMPA has conducted research to refine the relevant requirements and specific measures, and has issued the Announcement on Matters Concerning the Importation of Pre-Approval Commercial-Scale Batch Products of Overseas-Marketed Drugs (hereinafter referred to as the "Announcement"). This aims to shorten the time gap between drug approval and market supply in China, support the early use of innovative and clinically urgently needed drugs for the benefit of patients, and enhance the health and well-being of patients.
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NMPA Announcement on Optimizing of the Review and Approval Process for Clinical Trials of Innovative Drugs ([2025] No. 86)
2025-10-14
China's top legislator Zhao Leji on Wednesday met with Liberian Senate President Pro Tempore Nyonblee Karnga-Lawrence, who is in Beijing for the Global Leaders' Meeting on Women.
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Policy Interpretation of the Announcement on Optimizing of the Review and Approval Process for Clinical Trials of Innovative Drugs
2025-10-14
This announcement further refines resource allocation for review and approval, and promotes higher quality and efficiency in clinical development of innovative drugs.
