Analysis and insights into the changes of traditional Chinese medicine review and approval from 2020 to 2024

Abstract

The official release of the “Drug Registration Management Measures” in January 2020 marked a new milestone in the classification management of traditional Chinese medicine (TCM) registration, ushering in a new era for the registration and application of innovative TCM drugs. This article provides a detailed analysis of the approval status of innovative TCM drugs, improved new drugs, and ancient classic prescription compound preparations from 2020 to 2024, revealing the significant achievements made in the inheritance and innovation of TCM in China. The study found that the number of New Drug Applications (NDAs) and Investigational New Drug Applications (INDs) have increased annually, with a particularly notable surge in the submission of applications for classic prescription compound preparations. The approval rates for innovative TCM drugs and improved new drugs have significantly increased, along with the streamlining of review and approval process, leading to shorter development cycles and reduced costs. Key findings include: (1) Enterprises demonstrate strong enthusiasm for the research and development of innovative and improved TCM drugs, actively engaging in various types of drug R&D and submissions; (2) Classic prescription compound preparations have become a focal point for enterprises due to their shorter development cycles and lower costs; (3) Improvement to the “three-combined” evidence system has accelerated the R&D process by incorporating real-world data. Through this study, we aim to provide valuable insights for TCM R&D enterprises and policymakers, promoting the sustained prosperity and development of the TCM sector.

Keywords

Traditional Chinese medicine (TCM) / innovative drugs / review / approval / new drug application / clinical trial application / traditional classic prescription

References

[1] National People’s Congress. Traditional Chinese medicine Law of the People’s Republic of China. http://www.npc.gov.cn/zgrdw/npc/xinwen/2016-12/25/content_2004972.htm [12/25/2016].

[2] General Office of the Communist Party of China Central Committee & General Office of the State Council. Opinions on deepening the reform of the review and approval system to encourage innovation in drugs and medical devices. https://www.gov.cn/zhengce/2017-10/08/content_5230105.htm [10/08/2017].

[3] Communist Party of China Central Committee & State Council. Opinions on promoting the inheritance and innovative development of traditional Chinese medicine. https://www.gov.cn/gongbao/content/2019/content_5449644.htm [10/20/2019].

[4] State Administration for Market Regulation. Measures for the Administration of Drug Registration (Order No. 27 of the State Administration for Market Regulation). https://www.gov.cn/gongbao/content/2020/content_5512563.htm [03/30/2020].

[5] National Medical Products Administration. Special regulations for the registration management of traditional Chinese medicine. https://www.nmpa.gov.cn/xxgk/fgwj/xzhgfxwj/20230210173401120.html [02/10/2023].

[6] State Food and Drug Administration. Classification and submission requirements for the registration of traditional Chinese medicine and natural drugs. http://m.mofcom.gov.cn/article/bh/200707/20070704847505.shtml [07/03/2007].

[7] N ational M edical P roducts A dminis tration. Announcement on the issuance of “Requirements for the classification and submission of traditional Chinese medicine registration” (Announcement No. 68 of 2020). https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20200928164311143.html [09/28/2020].

[8] Center for Drug Evaluation, National Medical Products Administration. Announcement on the issuance of “Technical guidelines for research on improved new drugs of traditional Chinese medicine (Trial)””(Announcement No. 24 of 2024). https://www.cde.org.cn/main/news/viewInfoCommon/a1e6d2195a9a2c0f3cb7b2bc0ce88006 [05/15/2024].

[9] Yang HJ. Improved new drugs: A new direction for the development of major traditional Chinese medicine products. Chin J Pharmacol Toxicol, 2021, 35: 726.

[10] N ational M edical P roducts A dminis tration. Announcement on the issuance of simplified registration and approval regulations for classical famous prescriptions of traditional Chinese medicine compound preparations (Announcement No. 27 of 2018). https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20180601163901361.html [06/01/2018].

[11] Qu LP, Chen Y, Wang XL, et al. Analysis of the approval status of new traditional Chinese medicine registration in China from 2007 to 2019. Chin Tradit Herb Drugs, 2021, 52: 894-901.