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Announcement of the NMPA on the Release of the Good Manufacturing Practice for Medical Devices ([2025] No. 107)
2025-11-07
The National Medical Products Administration has revised the Good Manufacturing Practice for Medical Devices. It is hereby released and shall come into force as of November 1, 2026.
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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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Announcement of the National Medical Products Administration on Issuing Measures to Optimize Whole Life-Cycle Regulation in Support of the Innovative Development of High-End Medical Devices ([2025 ]No. 63)
2025-10-14
To thoroughly implement the principles of the Third Plenary Session of the 20th CPC Central Committee and the 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 improve the review and approval mechanisms, strengthen whole life-cycle regulation, fully support major innovations in high-end medical devices, promote the application of more new technologies, new materials, new processes, and new methods in the healthcare field, better meet public health needs, and enhance China's international competitiveness in high-end medical devices, the National Medical Products Administration hereby proposes the following supporting measures.
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NMPA CDE Announcement on Issuing the Patient-Centered Action for Rare Diseases Encouragement ("CARE Plan") ([2024] No. 500)
2025-09-05
In order to guide and support development entities in fully incorporating the patients' voices throughout the entire process of rare disease drug development, and to promote patient-centered drug development and marketing authorization for rare diseases, the CDE has organized the formulation of the Patient-Centered Action for Rare Diseases Encouragement ("CARE Plan").
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Patient-Centered Action for Rare Diseases Encouragement — "CARE Plan"
2025-09-05
The "CARE Plan" aims to uphold the concept of "patient-centered" drug development and encourages drug development entities to listen to patients' voices and pay attention to their experiences and perceptions throughout the development process for rare disease therapies.