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What are the measures to strengthen drug safety supervision during the “15th Five-Year Plan” period? Li Li, director of the China Drug Administration, said in an interview that during the “15th Five-Year Plan” period, how can the results of regulatory reform better benefit the public? Promote the improvement of the drug safety responsibility system. Comprehensively improve the ability to prevent and mitigate major risks, and promote the transformation of drug safety management from “passive defense” to “active prevention and control”. Strengthen the dynamic safety supervision of the whole chain. Give full play to the professional and technical advantages of drug regulatory authorities, focus on key aspects such as clinical trials, contract production, and online sales, actively respond to new challenges such as product innovation, technological innovation and business format innovation, improve the supervision mechanism covering the entire life cycle of R&D, production, operation and use, improve the standardized and unified inspection system, and continuously enhance the forward-looking, sharp, predictable and proactive drug supervision work. Strictly crack down on illegal acts. Standardize the administrative inspection practices of enterprises involved, strengthen supervision of the entire administrative enforcement process and normalization, and comprehensively raise the level of standardization of administrative law enforcement.

Zhitongcaijing·12/10/2025 14:01:43
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What are the measures to strengthen drug safety supervision during the “15th Five-Year Plan” period? Li Li, director of the China Drug Administration, said in an interview that during the “15th Five-Year Plan” period, how can the results of regulatory reform better benefit the public? Promote the improvement of the drug safety responsibility system. Comprehensively improve the ability to prevent and mitigate major risks, and promote the transformation of drug safety management from “passive defense” to “active prevention and control”. Strengthen the dynamic safety supervision of the whole chain. Give full play to the professional and technical advantages of drug regulatory authorities, focus on key aspects such as clinical trials, contract production, and online sales, actively respond to new challenges such as product innovation, technological innovation and business format innovation, improve the supervision mechanism covering the entire life cycle of R&D, production, operation and use, improve the standardized and unified inspection system, and continuously enhance the forward-looking, sharp, predictable and proactive drug supervision work. Strictly crack down on illegal acts. Standardize the administrative inspection practices of enterprises involved, strengthen supervision of the entire administrative enforcement process and normalization, and comprehensively raise the level of standardization of administrative law enforcement.