OBJECTIVES:The National Medical Products Administration (NMPA) in China has set to advance the regulatory capacity of TCM with the adoption of regulatory science (RS). However, the priority of actions at the interface of RS and TCM were yet to be defined. This research aims to identify the priority areas and summarize core actions for advancing RS for traditional medicines in China and abroad.

METHODS:An integrative approach of documentary analysis of government policies, regulations and official information about TCM regulation in China, and a scoping review of literature using 4 databases (PubMed, ScienceDirect, Scopus and CNKI) on major concerns in TCM regulation was employed.

RESULTS:Ten priority areas the in the development of TCM-related regulatory science in China have been identified, including: (1) modernizing the regulatory system with product-based regulatory measures; (2) advancing the quality control of TCMs with novel evaluation methods using biomarker; (3) improving product manufacturing quality with process analytical technology and quality-by-design approaches; (4) encouraging innovation in clinical evaluation leveraging evidence-based evaluations and real-world data; (5) re-evaluating TCM injection that emphasizes on quality controllability and risk evaluation and management; (6) developing expedited review process for classic TCM formula that considers real-world evidence of safety and efficacy; (7) harnessing diverse data to improve surveillance of raw materials and end-products of TCMs; (8) aggregating evidence of integrative medicine that supports its fitting into existing models of scientific research and clinical practice; (9) encouraging the innovation of delivery systems using nanotechnology and complex dosage forms; and (10) fostering the capacity of advancing TCM regulatory standards through collaboration and partnership.

CONCLUSIONS:RS for TCM in China encompasses revolution of operational procedures, advancement in science and technology, and cross-boundary collaborations. Such experiences should be used to facilitate communications among drug regulatory authorities to promote standardized and scientific regulation of traditional medicines.