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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.
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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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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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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.
