上海：支持疗效确切、特色优势明显的医疗机构中药制剂及名老中医方开发转化为中药新药

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, with a particular focus on supporting traditional Chinese medicine (TCM) innovation [1] Group 1: Support for Traditional Chinese Medicine - The measures include establishing a mechanism for medical institutions to systematically collect and organize human experience data, exploring its use as real-world evidence for drug registration applications [1] - Regulations will be formulated for the filing management of TCM preparations made using traditional processes in medical institutions [1] - The government will support the development and transformation of effective TCM preparations and classic formulas from renowned TCM practitioners into new TCM drugs [1] Group 2: Collaboration and Innovation Platforms - Medical institutions, research units, and pharmaceutical companies are encouraged to collaboratively create platforms for TCM innovation and industrial transformation [1] - Support will be provided for clinical research on innovative TCM drugs and the study of classic TCM compound preparations [1] - The cultivation of major TCM varieties and the secondary development of classic varieties will be promoted [1] Group 3: Regulatory Flexibility - TCM formula granules produced in other provinces according to national drug standards will be exempt from filing requirements when sold in Shanghai [1]