On November 24, the General Office of the Shanghai Municipal People's Government unveiled the "Several Measures for Comprehensively Advancing the Reform of Drug and Medical Device Regulation to Foster High-Quality Growth in Shanghai's Pharmaceutical Sector." This initiative aims to bolster service capabilities by focusing on pivotal areas and products, including cell and gene therapies, treatments for rare diseases, pediatric pharmaceuticals, high-quality generic drugs, AI-powered medical devices, medical robots, brain-computer interfaces, particle therapy systems, and innovative diagnostic and therapeutic tools rooted in traditional Chinese medicine.

A dedicated service list will be compiled for key products in development, offering proactive guidance throughout various stages: clinical trials, registration and market introduction, inspections, and production licensing. To enhance support, a coordinated service mechanism spanning national, municipal, and district levels will be solidified. This will bolster the capacity-building efforts of the Yangtze River Delta Sub-center of the National Medical Products Administration for Drug Evaluation and Inspection, as well as the Yangtze River Delta Sub-center for Medical Device Technical Evaluation and Inspection.

Efforts will be accelerated to expand and upgrade district-level biological medicine product registration guidance service stations. These stations will engage in gathering information on innovative products in development, providing proactive guidance, and offering tracking services for critical projects. The ethical review collaboration mechanism among healthcare institutions will be refined, featuring streamlined and standardized application materials and processes, more frequent review meetings, and reduced review times. This will encourage multi-center clinical trial ethical review collaboration across the Yangtze River Delta region.

Furthermore, standardization of clinical medical data will be emphasized to enhance its utilization in research and development innovation. A clinical value-driven screening and assessment framework for innovative medical devices will be established, with the goal of accelerating their path to commercialization.