近日，省药监局印发贯彻落实《安徽省全面深化药品医疗器械监管改革促进医药产业高质量发展若干措 施》（以下简称《若干措施》）清单，对涉及药品监管领域职能职责的措施进行细化分解，推动各项改 革任务落地见效。 对《若干措施》中涉及其他部门职责的改革措施，省药监局将推动纳入2026年全省药品安全工作要点进 行统筹部署与协同推进，确保我省各项改革举措全面落实、形成合力，推动我省医药产业高质量发展。 （来源：市场星报） 清单紧紧围绕《若干措施》部署的改革措施进行系统承接与细化，聚焦药品监管实际，针对强化药械研 发跟踪服务、支持服务中药新药上市、加强审评审批能力建设、提高药械监督检查效率、提升医药流通 新业态监管质效、大力提升智慧监管水平等18项具体改革举措，细化分解贯彻落实任务清单90项，并逐 项明确工作目标、责任处室单位和完成时限，实行清单化、闭环式管理。 ...

Core Viewpoint - The Shandong Provincial Government has issued an implementation opinion aimed at deepening the reform of drug and medical device regulation to promote high-quality development in the pharmaceutical industry, marking a significant step in enhancing drug safety and industry development [1][2]. Group 1: Key Measures - The implementation opinion outlines 29 measures across six areas to strengthen the cultivation of pharmaceutical innovation, support cutting-edge technology, enhance innovation platform construction, and promote the transformation of innovative drugs and devices [2]. - It aims to optimize the clinical trial ecosystem by encouraging medical institutions to undertake trials, improving the efficiency of ethical reviews, promoting the application of AI technology, and enhancing institutional management and services [2]. - The reform of review and approval processes is emphasized, including proactive alignment with the National Medical Products Administration, support for generic drug services, and the promotion of smart regulation for traditional Chinese medicine [2]. Group 2: Promotion and Internationalization - The opinion promotes the clinical use of innovative products by establishing a catalog of innovative products, accelerating the listing process, and improving the medical insurance payment mechanism [2]. - It encourages the international development of the industry through targeted investment attraction, supporting the export of raw materials and formulations, and enhancing international cooperation [2]. - There is a focus on strengthening quality supervision throughout the entire process, ensuring corporate responsibility, enhancing smart regulatory capabilities, and cracking down on illegal activities [2].

Core Viewpoint - The Shandong provincial government has issued an implementation opinion aimed at deepening the reform of drug and medical device regulation, promoting high-quality development in the pharmaceutical industry through 29 specific measures across six key areas [2]. Group 1: Strengthening Innovation - The implementation opinion emphasizes the importance of medical innovation, focusing on cutting-edge areas such as gene therapy, cell therapy, synthetic biology, AI-assisted drug design, new vaccines, radioactive drugs, high-end medical devices, and modernization of traditional Chinese medicine [2]. - Shandong will support projects with significant original innovations and breakthroughs through provincial science and technology programs, enhancing the innovation platform system and encouraging enterprise-led innovation [2]. Group 2: Regulatory Efficiency - The reform aims to enhance efficiency by streamlining the review and approval process, integrating with the Beijing-Tianjin-Hebei review center to access more resources for drug and medical device evaluations [4]. - A scientific tiered review mechanism will be established, providing dedicated support for key innovative products while optimizing standardized review processes for routine projects to improve efficiency [4]. - The reform represents a systematic restructuring and digital transformation of the review and approval system, promoting full online processing of drug and medical device registrations and licenses, allowing for a more efficient workflow [4].

Core Viewpoint - The Shandong provincial government has issued a policy document aimed at enhancing drug and medical device regulation to promote high-quality development in the pharmaceutical industry, marking a significant step in reforming drug regulation and advancing the industry in the province [3]. Group 1: Policy Overview - The document titled "Implementation Opinions on Deepening Drug and Medical Device Regulation Reform to Promote High-Quality Development of the Pharmaceutical Industry" outlines 29 measures across six key areas [4]. - The initiative emphasizes the importance of drug and medical devices as critical goods for public health and economic development, reflecting the central government's commitment to drug safety [3]. Group 2: Key Measures - Strengthening the cultivation of pharmaceutical innovation by supporting cutting-edge technology, enhancing innovation platform construction, and promoting the transformation of innovative drugs and devices [4]. - Optimizing the clinical trial ecosystem by encouraging medical institutions to undertake trials, improving ethical review efficiency, and applying AI technology [4]. - Deepening review and approval reforms by aligning with national drug regulatory frameworks and enhancing the service system for drug production and innovation [4]. - Promoting the clinical use of innovative products by establishing a catalog of innovative products and improving the medical insurance payment mechanism [4]. - Encouraging international development of the industry through targeted investment attraction and enhancing international cooperation [4]. - Strengthening quality supervision throughout the process by enforcing corporate responsibility and enhancing smart regulatory capabilities [4].

Core Viewpoint - The Shanghai government has officially issued measures to deepen the reform of drug and medical device regulation, aiming to promote high-quality development in the pharmaceutical industry through 22 specific initiatives across six key areas [1][4]. Group 1: Support for R&D Innovation - The measures include support for innovative drug development and the establishment of pilot projects for continuous manufacturing of drugs [2][5]. - There is a focus on expediting the review and approval processes for innovative drugs and medical devices, including shortening clinical trial approval times to 30 working days [8]. Group 2: Enhancing Review and Approval Efficiency - The measures aim to improve the efficiency of the review and approval process by reducing the average registration cycle for Class II medical devices to within six months [8]. - The approval time for seasonal flu vaccine batch issuance has been reduced to 30 working days [8]. Group 3: Expanding High-Level Open Cooperation - The initiative encourages the establishment of shared laboratories among medical device manufacturers and supports third-party logistics companies in setting up warehouses across provinces [2][5]. - It also promotes international collaboration by supporting the conduct of international multi-center clinical trials for innovative drugs and medical devices [5]. Group 4: Strengthening Regulatory Capacity - The measures emphasize the need for enhanced regulatory capabilities, including the establishment of a feedback mechanism for the efficacy of collected drugs [2][7]. - There is a commitment to improving the legal foundation for high-quality innovation in drugs and medical devices, aligning with national policies [4]. Group 5: Full Lifecycle Regulation - The initiative includes a focus on full lifecycle regulation, ensuring that regulatory services are provided from clinical trials to product registration and market entry [7]. - The measures also aim to optimize the process for changes to already marketed drugs, enhancing the overall regulatory framework [5].

Core Viewpoint - Beijing has implemented six significant regulatory reforms approved by the National Medical Products Administration to promote high-quality development in the pharmaceutical industry, focusing on rare diseases and urgent clinical needs [1][2]. Group 1: Regulatory Reforms - The establishment of a green channel for the approval of urgently needed imported drugs and medical devices has led to the approval of 26 drug varieties, including 21 for rare diseases, benefiting over 4,900 patients [1]. - The clinical trial approval time for innovative drugs has been reduced from 60 working days to 30, with some projects approved in as little as 18 working days [1][2]. - The supplementary application review time has been cut from 200 working days to 60, with 33 pre-service applications received and the fastest approval in 19 working days [2]. Group 2: Import and Commercialization - Beijing has facilitated the import of 27 commercial-scale batches of previously listed overseas drugs, with a total customs value of 5.007 billion yuan [2]. - The number of pilot medical institutions for self-research and use of in vitro diagnostic reagents has increased from 6 to 15, completing the filing of 5 products [2]. Group 3: Innovation and Efficiency - The establishment of a national-level medical device innovation service station has served over 1,200 enterprises and resolved more than 3,000 consultation issues [3]. - The average review time for the first registration of Class II medical devices has been reduced to 45 working days, a 63% improvement over the legal limit of 120 working days [3]. - The Beijing Vaccine Inspection Center, the first of its kind in the country, is expected to be operational by the end of this year, capable of meeting the annual inspection demand for 4,000 vaccine batches [3].

Core Viewpoint - The establishment of regional centers for drug and medical device review and inspection by the National Medical Products Administration (NMPA) is a significant step towards enhancing regulatory reforms and promoting high-quality development in the pharmaceutical industry across various regions in China [1] Group 1: Regional Development Strategy - The NMPA's new centers in Beijing-Tianjin-Hebei, Central China, and Southwest China aim to support major regional development strategies, including coordinated development in the Beijing-Tianjin-Hebei area, the rise of Central China, and the promotion of Western China's development [1] - These centers are intended to deepen the regulatory reform of drugs and medical devices, aligning with national strategies for regional growth [1] Group 2: Collaboration and Implementation - The NMPA plans to work closely with local governments in Beijing, Hubei, and Chongqing to implement cooperation agreements and ensure the effective operation of the new centers [1] - The focus will be on comprehensive execution of responsibilities and efficient functioning of the centers to enhance the local pharmaceutical industry [1]

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].