B · Normal
[Shanghai: Comprehensively strengthen supervision of drug research institutions and establish and improve a hierarchical and classified supervision mechanism for research institutions] On November 9, the Shanghai Food and Drug Safety Commission issued the "Shanghai Fifteenth Five-Year Plan to Ensure Drug Safety and Promote High-Quality Development of the Pharmaceutical Industry." It mentioned that the supervision of drug research institutions should be comprehensively strengthened. Promote relevant research institutions to strictly implement Good Practice for Drug Non-clinical Research (GLP) and Good Clinical Practice for Drugs (GCP), strengthen inspections of data authenticity, completeness, and standardization, and severely crack down on data fraud and other illegal activities. Establish and improve a hierarchical and classified supervision mechanism for research institutions. Carry out the collection and evaluation of drug clinical trial management information, establish credit files for drug clinical trial institutions, and build and improve a drug clinical trial supervision platform. Form a batch of drug clinical trial management experience that can be replicated and promoted. Continue to strengthen the standardized management of the entire process of medical device clinical trials. Build a medical device clinical trial supervision platform, implement the registration and project management requirements of medical device clinical trial institutions, highlight the supervision of institutional management systems, process control and data traceability, and strengthen post-registration supervision and inspection, project spot checks, safety information processing and risk research and judgment.
Futures Market Intelligence 🕐 2026-11-09 14:55

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