上海出台《若干措施》 多措并举助力打造世界级生物医药产业高地

Core Viewpoint - The Shanghai government has introduced measures to enhance drug and medical device regulation, aiming to promote high-quality development in the pharmaceutical industry through reforms and improved services [1][2]. Group 1: Key Measures - The measures include 22 initiatives focusing on supporting research and development, enhancing review and approval efficiency, expanding high-level open cooperation, and strengthening regulatory capacity [1][2]. - Shanghai aims to accelerate the review and approval of overseas drug production applications and generic drug assessments, as well as promote pilot projects for biopharmaceuticals and cross-border production [2][3]. Group 2: Innovation and Technology - The integration of artificial intelligence with the pharmaceutical industry is emphasized, promoting AI applications in drug discovery, regulatory processes, and risk management [3]. - The establishment of a technology innovation base for pharmaceuticals and medical devices is planned, enhancing the use of AI in regulatory practices [3]. Group 3: Insurance and Accessibility - The Shanghai Medical Insurance Bureau will facilitate communication between insurance companies and innovative drug firms, exploring payment mechanisms based on treatment effectiveness to improve accessibility to innovative drugs and devices [3]. - The measures encourage the inclusion of new medical technologies and products in commercial health insurance coverage to meet diverse public needs [3]. Group 4: Intellectual Property Protection - Strengthening intellectual property protection is a key aspect of the measures, including expedited patent review services and enhanced administrative enforcement against patent infringement [3][4]. - The Shanghai Intellectual Property Bureau will focus on optimizing patent services, increasing administrative protection, and promoting patent commercialization to support industry development [4].