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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.
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NMPA CDE Announcement on Issuing the Technical Guideline for Safety Information Assessment and Reporting in Pediatric Drug Clinical Trials (Interim) ([2025] No. 21)
2025-09-05
In order to standardize the risk monitoring, identification, assessment, and control of safety information in pediatric drug clinical trials, the CDE, under the deployment of the NMPA, has organized the formulation of the Technical Guideline for Safety Information Assessment and Reporting in Pediatric Drug Clinical Trials (Interim).
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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.
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Policy Interpretation of the Quality Management Specifications for Online Sales of Medical Devices
2025-07-21
With the rapid development of e-commerce, the online medical device sales market in China has experienced explosive growth in recent years. According to statistics, from 2018 to the present, the number of medical device distributors engaged in online sales has increased from 8,717 to over 360,000, while the number of third-party platform enterprises has grown from 77 to 851.
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Policy Interpretation of Provisions on the Experimental Research of Narcotic Drugs and Psychotropic Substances
2025-07-21
To strengthen the safety management of experimental research involving narcotic and psychotropic drugs, the Provisions propose requirements from multiple aspects, including safety management systems and facilities and equipment, entrusted research management, management of experimental researchers, and management of narcotic and psychotropic drugs and active substances.