中药生产监督管理专门规定发布 突出全链条、全环节和全过程质量控制

Core Viewpoint - The National Medical Products Administration has announced new regulations for the supervision of traditional Chinese medicine (TCM) production, effective from March 1, 2026, emphasizing comprehensive quality control throughout the entire production process [1]. Group 1: Regulatory Framework - The new regulations focus on controlling the quality of TCM from the source of raw materials to production, release, post-market monitoring, and risk management [1]. - The regulations aim to address key issues affecting TCM production and quality, proposing targeted solutions for the standardized development of TCM materials [1]. Group 2: Quality Management - There is an emphasis on the quality assessment of TCM materials, strengthening supplier audits, and promoting the implementation of Good Agricultural Practices (GAP) for TCM materials [1]. - TCM enterprises are encouraged to extend their quality management systems throughout the entire production process of TCM materials, thereby reducing intermediaries in the supply chain [1]. Group 3: Production Process Control - The regulations call for enhanced quality control during the production process, optimization of process validation requirements, and clear guidelines for uniform processing and extraction deviation control [1]. - There is a focus on the research validation and supervision management of entrusted and contracted production of TCM, as well as strict oversight of TCM injection production to ensure quality [1].