上海发布若干措施 全面深化药品医疗器械监管改革

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].