药品审评审批制度改革
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国家药监局:科学制定“十五五”药品规划 全面深化药品审评审批制度改革
Zhong Zheng Wang· 2025-08-29 03:24
Core Viewpoint - The National Medical Products Administration emphasizes the importance of formulating the "14th Five-Year" drug planning to enhance drug regulation capabilities and promote high-quality development of the pharmaceutical industry, aiming to transition China from a major pharmaceutical country to a strong pharmaceutical nation [1] Group 1: Drug Regulation Development - The meeting highlighted the need to develop an overall strategy for drug regulation during the "14th Five-Year" period [1] - It aims to address deep-seated contradictions and issues in drug regulation, enhancing governance capabilities [1] - The focus is on creating a comprehensive drug safety responsibility system and a full-chain regulatory mechanism [1] Group 2: Reform and Innovation - There is a call for comprehensive deepening of drug review and approval system reforms [1] - The meeting encourages the innovation and development of traditional Chinese medicine and high-end medical devices [1] - It also emphasizes the need to reform the review and approval mechanisms for cosmetics to promote high-quality development [1] Group 3: Regulatory Capacity Building - The meeting stresses the importance of improving the regulatory standards and legal framework [1] - It highlights the need for strengthening technical support capabilities and leading with information technology [1] - The goal is to build a high-quality team of drug regulatory professionals to enhance overall regulatory capabilities [1]
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]