中药生产监督迎来新规 明年3月1日起施行

Core Viewpoint - The National Medical Products Administration (NMPA) has announced the implementation of the "Special Regulations on the Supervision and Management of Traditional Chinese Medicine Production," effective from March 1, 2026, aimed at enhancing the quality control of traditional Chinese medicine (TCM) production throughout the entire process [1][2]. Group 1: Regulatory Framework - The new regulations are based on existing drug production supervision and quality management standards, tailored specifically for the characteristics of TCM production [1]. - The regulations emphasize comprehensive quality control from the source of TCM materials to the final product release and post-market monitoring [1][2]. Group 2: Quality Control Measures - The regulations stress the importance of evaluating the quality of TCM materials, enhancing supplier audits, and promoting standardized management practices throughout the production process [2]. - There is a focus on optimizing production process quality control, including specific requirements for uniform processing and extraction deviation control [2]. Group 3: Technological Integration - The regulations encourage the adoption of modern technologies such as artificial intelligence and smart manufacturing to enhance the quality, efficiency, and sustainability of the pharmaceutical industry [2]. - Companies are urged to extend their quality management systems to cover the entire TCM material production process, utilizing automation and digitalization to improve monitoring and record-keeping [2].