The “Special Provisions for the Supervision and Administration of Traditional Chinese Medicine Production” is China’s first regulatory document specifically designed to systematically regulate the oversight of traditional Chinese medicine (TCM) production. It signifies a deepening shift from general requirements to a specialized system that reflects the unique characteristics of TCM manufacturing. This development helps to enhance the standardization of TCM production and the stability of its quality, modernize regulatory approaches, and provide institutional support for building a drug regulation system tailored to TCM’s features, thereby promoting the high-quality development of the TCM industry. Grounded in the inherent characteristics of TCM-such as the natural origin of its raw materials, long quality formation chains, and complex influencing factors-the provisions establish a regulatory framework covering the entire TCM production lifecycle. This framework addresses key areas including source control of Chinese medicinal materials, production process management, testing and release, traceability systems, pharmacovigilance, and regulatory oversight. The institutional design emphasizes adherence to TCM principles, strengthens the subject responsibility of the marketing authorization holder, highlights source control, rigorous process management, and risk-based classification supervision. Furthermore, it provides detailed requirements for critical issues such as raw material homogenization, extract yield management, contract manufacturing, production resumption, and the oversight of TCM injections. By analyzing the background of its issuance, institutional logic, main content, key innovations, and implementation pathways, this paper aims to facilitate a deeper understanding of the significance of implementing these Special Provisions among the industry.

traditional Chinese medicine production  /  supervision and administration  /  regulatory science of traditional Chinese medicine  /  entire lifecycle  /  classified supervision  /  subject responsibility  /  quality control