Core Viewpoint - Shanghai is implementing a series of measures to enhance the efficiency of the approval and application processes for innovative drugs and medical devices, aiming to reduce the hospital admission process for critical new drugs from 30 days to 15 days [1][2]. Group 1: Policy Measures - The newly issued "Several Measures" includes six areas with a total of 22 items aimed at promoting the development of the pharmaceutical and medical device industry through regulatory reforms [1][2]. - Key areas of focus include supporting research and development innovation, enhancing review and approval efficiency, expanding high-level open cooperation, and constructing a full lifecycle regulatory framework [2][4]. Group 2: Innovation Acceleration - The measures emphasize accelerating the application of innovative products by optimizing the listing services for new drugs and exploring efficient mechanisms for the transition from research to application [2][3]. - Shanghai aims to become the first province to list new innovative drugs, which could serve as a reference for other regions [3]. Group 3: Internationalization and Standards - The measures propose to align with international standards to facilitate the export of domestic pharmaceutical and medical device products, including supporting international clinical trials and enhancing the recognition of domestic testing institutions [5][6]. - The importance of addressing regulatory challenges faced by companies during international expansion is highlighted, with a focus on improving service levels and introducing high-quality overseas resources [6].
上海22条新政赋能创新药械,入院周期、产品出海全面提速
Di Yi Cai Jing·2025-11-26 12:29