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药品审评审批制度改革
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中办、国办:探索将国际新药临床真实世界数据用于进口药品注册上市许可的可行路径
news flash· 2025-06-10 10:01
Core Viewpoint - The document emphasizes the exploration of feasible pathways to utilize international new drug clinical real-world data for the registration and licensing of imported pharmaceuticals in China [1] Group 1: Regulatory Reforms - The document outlines the need to deepen the reform of the drug and medical device review and approval system [1] - It highlights the enhancement of drug supervision and inspection capabilities at ports [1] - The document mentions the improvement of management systems for urgently needed imported drugs and medical devices [1] Group 2: Digital Governance - The document calls for the advancement of digital government reforms to elevate the level of intelligent and specialized social governance [1]