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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.
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The 4th Seminar on the Research and Development of Pediatric Drugs Successfully Held in Beijing
2025-09-05
The 4th Seminar on the Research and Development of Pediatric Drugs was successfully held in Beijing on June 6, 2025. This event was co-hosted by the Center for Drug Evaluation (CDE) and the China Center for Food and Drug International Exchange (CCFDIE) of NMPA.
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Support Anti-Tumor Drug R&D for Kids — SPARK Plan
2025-09-05
The "Support Anti-Tumor Drug R&D for Kids (SPARK Plan)" is a pilot work launched by the CDE to implement the NMPA's principles of "early engagement, tailored guidance, full-process support, and coordinated review". Building upon the "Patient-Centered Action for Rare Diseases Encouragement (CARE Plan)", the SPARK Plan is carried out in the field of pediatric drug development.
