药械监管改革

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山西出台28项举措深化药械监管改革
Zhong Guo Chan Ye Jing Ji Xin Xi Wang· 2025-06-19 22:25
Core Viewpoint - The Shanxi Provincial Government has introduced measures to enhance the regulation of pharmaceuticals and medical devices, aiming to promote high-quality development in the pharmaceutical industry while responding to industry needs and releasing policy dividends [1][2]. Group 1: Support for R&D and Innovation - The measures propose six specific actions to strengthen key core technology breakthroughs, accelerate the transition of drug research to clinical trials, encourage the R&D and industrialization of innovative drugs and devices, promote traditional Chinese medicine innovation, enhance standard leadership, and strengthen intellectual property protection [2]. Group 2: Improving Review and Approval Efficiency - Seven specific actions are outlined to optimize the review and approval mechanisms, expedite the approval of urgently needed drugs and medical devices, enhance clinical trial review processes, improve service efficiency in reviews, optimize registration inspections, accelerate the review of drugs and devices for rare diseases, and implement international regulatory standards [2]. Group 3: Promoting Application of Innovative Products - The measures encourage enterprises to increase the application of innovative results, expedite the use of innovative drugs and medical devices in hospitals, enhance medical insurance payments, and optimize import and export support through four specific actions [2]. Group 4: Enhancing Compliance through Effective Regulation - Seven specific actions are emphasized to strictly fulfill regulatory responsibilities, integrate regulation with service, ensure high-level safety for high-quality development, promote the authorization of biological product batch release, enhance the quality of generic drugs, facilitate the digital transformation of pharmaceutical enterprises, improve inspection efficiency, strengthen drug vigilance, and support new business models in pharmaceutical distribution [2][3]. Group 5: Building a Regulatory System Aligned with Industry Needs - Four specific actions are proposed to establish a sound drug safety responsibility system, enhance regulatory capacity building, strengthen regulatory scientific research, and advance regulatory information technology [3]. Implementation Focus - The Shanxi Provincial Drug Administration will focus on the effective implementation of these measures, aiming to deepen pharmaceutical regulatory reforms, ensure drug safety throughout the entire cycle, support high-quality development of the pharmaceutical industry across the entire chain, and enhance regulatory capabilities to allow more enterprises to benefit from the reforms [3].