山西出台药品医疗器械监管改革新规 28项举措促发展

Core Viewpoint - Shanxi Province is implementing a series of 28 specific measures to enhance the regulation and development of the pharmaceutical and medical device industry, aiming for high-quality growth in the sector [1][2]. Group 1: Support for R&D Innovation - The measures emphasize strengthening key core technology breakthroughs, accelerating the transition of drug research to clinical trials, encouraging the development and industrialization of innovative drugs and devices, promoting traditional Chinese medicine innovation, enhancing standard leadership, and strengthening intellectual property protection [1]. Group 2: Improvement of Review and Approval Efficiency - The measures include optimizing the review and approval mechanisms, expediting the approval of urgently needed drugs and medical devices, improving clinical trial review processes, enhancing service efficiency in approvals, optimizing registration inspections, accelerating the review of drugs and devices for rare diseases, and advancing the implementation of internationally accepted regulatory rules [2]. Group 3: Promotion of Innovative Product Application - 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 [2]. Group 4: Enhancing Compliance through Effective Regulation - The measures stress the importance of strict regulatory responsibilities, integrating regulation with service, and ensuring high-level safety to support high-quality development, including promoting the authorization of biological product batch release and improving the quality of generic drugs [2]. Group 5: Building a Regulatory System Aligned with Industry Needs - The measures propose to improve the drug safety responsibility system, enhance regulatory capacity building, strengthen regulatory scientific research, and advance regulatory information technology construction [2]. Implementation Timeline - The measures will take effect on June 16, with a commitment to deepen pharmaceutical regulation reforms and support high-quality development in the industry [2].