Core Viewpoint - The Shanghai Municipal Government has issued measures to deepen the reform of drug and medical device regulation, aiming to promote high-quality development in the pharmaceutical industry, focusing on key areas such as cell and gene therapy, rare diseases, and pediatric medications [1] Group 1: Key Areas of Focus - The measures emphasize the importance of specific fields and products, including cell and gene therapy, rare diseases, pediatric medications, high-quality first generic drugs, artificial intelligence medical devices, medical robots, brain-machine interfaces, particle therapy equipment, and innovative traditional Chinese medicine diagnostic and treatment devices [1] Group 2: Regulatory Support - A service list for key varieties under research will be established, providing proactive guidance in clinical trials, registration and listing, inspections, and production licensing [1]

Core Viewpoint - The Shanghai Municipal Government has issued measures to enhance the regulation of pharmaceuticals and medical devices, aiming to promote high-quality development in the pharmaceutical industry [1] Group 1: Regulatory Enhancements - Strengthening standard leadership by actively participating in the formulation and revision of national standards for pharmaceuticals and medical devices, as well as coordinating international standards [1] - Promoting the standardization research of cutting-edge technologies such as artificial intelligence medical devices, medical robots, brain-computer interfaces, particle therapy equipment, innovative traditional Chinese medicine diagnostic devices, and cell and gene therapy [1] Group 2: Traditional Chinese Medicine Standards - Continuing the research on standards for traditional Chinese medicine pieces, formula granules, and medical devices, relying on international standardization platforms like the International Organization for Standardization/Traditional Chinese Medicine Technical Committee (ISO/TC249) to establish international standards for traditional Chinese medicine [1] Group 3: Digitalization and Traceability - Supporting the formulation of group standards for the digital traceability of the production processes of pharmaceuticals and medical devices [1]