药品委托生产监管
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强化药品委托生产全链条监管
Xin Lang Cai Jing· 2026-01-13 21:58
Group 1 - The core viewpoint of the announcement is to enhance the quality and safety assurance of contract-manufactured pharmaceuticals through clarified responsibilities and strengthened management systems [1][2] Group 2 - The announcement emphasizes the responsibilities of contract manufacturers, requiring them to evaluate the license holders and products before accepting contracts, and detailing requirements for technical transfer, risk management, and quality communication [1] - It outlines the procedures for handling production licenses and management requirements for high-risk products, mandating provincial drug regulatory authorities to assess key personnel's capabilities and enhance inspection and cooperation [1][2] Group 3 - The announcement encourages innovation in drug production and the use of information management systems to promote industry transformation, while also detailing risk management for co-production and requiring evaluations for any significant changes in production conditions [2] - Specific requirements for contract manufacturing of high-risk products, such as sterile drugs and traditional Chinese medicine injections, are established, including experience prerequisites for key personnel involved in production and quality management [2]