ORIGINAL RESEARCH article
Front. Med.
Sec. Regulatory Science
Volume 12 - 2025 | doi: 10.3389/fmed.2025.1559703
Promoting the Development and Approval of New Traditional Chinese Medicines in China: a Pooled Analysis of Data from 2013-2024
Provisionally accepted
- School of Business Administration, Shenyang Pharmaceutical University, Shenyang, China
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The reform of the development and approval system for traditional Chinese medicines (TCMs) has been in progress for several years. This reform has restructured the registration classifications and established a distinctive evaluation and registration evidence system for TCMs. This study compiled comprehensive data on all new TCMs approved in China from January 2013 to November 2024, analyzing drug characteristics and the changes in development and review timelines before and after the reform. The focus was particularly on the evaluation and registration evidence requirements, clinical development pathways, and the application of pivotal clinical and real-world evidence in supporting TCM approvals. Between 2013 and 2024, 77 new TCMs were approved for marketing. Post-reform, there has been a gradual increase in the number of new TCMs, with a notably significant rise in ancient classic formulas. Following 2020, the establishment of the 'three-in-one' evaluation and registration evidence system was implemented to accommodate the distinct characteristics of TCMs. This system revealed significant discrepancies in the registration classifications for new TCMs, particularly concerning TCM theory, human application experience, and clinical trials. These discrepancies have led to varied clinical development pathways. Importantly, the findings suggest that the marketing approval of new TCMs is no longer solely reliant on Randomized Controlled Trials. Instead, TCM theories and empirical human use experience constitute critical evidence for TCM approval. Additionally, evidence derived from real-world studies has become instrumental in supporting the marketing of TCMs. Although the review time for TCMs has significantly decreased after the reform, the overall development time has increased. Simultaneously, this article proposed specific recommendations to address the array of challenges encountered by new TCMs in the realms of development and approval.
Keywords: Traditional Chinese Medicine, Evaluation and registration evidence, clinical trials, Development and approval reform, China
Received: 13 Jan 2025; Accepted: 19 May 2025.
Copyright: © 2025 Long, Zhang and Yang. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Li Yang, School of Business Administration, Shenyang Pharmaceutical University, Shenyang, China
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.