Core Points - The article discusses the implementation of the "Several Measures for Deepening Drug and Medical Device Regulation Reform in Shanxi Province" aimed at promoting high-quality development in the pharmaceutical industry [1][2] Group 1: Support for R&D Innovation - The measures include six specific actions to support drug and medical device R&D innovation, such as strengthening core technology research, accelerating drug development to preclinical research, and encouraging the innovation and industrialization of drugs and devices [1] Group 2: Improvement of Review and Approval Efficiency - Seven specific actions are proposed to enhance the quality and efficiency of drug and medical device review and approval processes, including optimizing review mechanisms and expediting the approval of urgently needed drugs and devices [1][2] Group 3: Promotion of Innovative Product Application - Four specific actions are outlined to accelerate the application and promotion of innovative products, such as encouraging enterprises to increase the application of innovative results and optimizing support for imports and exports [1] Group 4: Regulatory Compliance Enhancement - The measures emphasize strict regulatory responsibilities and propose seven specific actions to improve compliance levels in the pharmaceutical industry, including promoting the quality enhancement of generic drugs and increasing the efficiency of supervision and inspection [2] Group 5: Development of a Regulatory System - Four specific actions are suggested to build a regulatory system that aligns with industry development and safety needs, such as strengthening regulatory capacity building and advancing regulatory information technology [2]

Core Points - The provincial government is implementing reforms to accelerate the approval process for innovative medical devices and drugs, including establishing a green channel for priority reviews and compressing inspection timelines to enhance market access [1][2] Group 1: Approval Process Optimization - The provincial drug regulatory authority has introduced measures to optimize the review and approval mechanism, including a proactive approach with tailored strategies for each product and dedicated support teams [1] - The approval process for drug changes has been streamlined, reducing the minimum processing time for site changes from 195 days to 105 days, achieving an overall time reduction of over 40% [1] Group 2: Inspection and Registration Improvements - The registration inspection for low-risk drug varieties has been optimized, with the required batch quantity for inspection reduced from three times to two times the full inspection quantity [2] - The inspection timeline for registered medical devices has been compressed to 20 working days, and emergency approvals are being implemented to expedite the process for urgently needed medical devices and drugs [2] Group 3: Focus on Rare Diseases and Urgent Needs - The approval process for drugs and medical devices related to rare diseases has been expedited, with the number of required inspection batches reduced from three to one, and the batch quantity requirement also decreased [2] - Clinical urgent medical devices are prioritized in the approval process, with the approval timeline reduced from 58 working days to 30 working days [2]

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].