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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.
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NMPA holds meeting to review QMS in vaccine regulation, pharmaceutical manufacturing inspection
2025-07-21
The National Medical Products Administration (NMPA) held a meeting on June 9 to conduct the 2024 annual review of the quality management system (QMS) in vaccine regulation and pharmaceutical manufacturing inspection. NMPA Commissioner Li Li chaired the meeting and fully affirmed the suitability, adequacy, and effectiveness of the NMPA's QMS in these two areas.
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NPMA Announcement on Expanding the Implementation Scope of Electronic Common Technical Documents (No.10, 2025)
2025-06-11
To accelerate the implementation process of the Electronic Common Technical Document (eCTD) in China and enhance the service capabilities of "Internet + Drug Regulation" applications, the following matters concerning the expansion of the eCTD implementation scope are hereby announced.
