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].