Expert consensus on the positioning of the “Three-in-One” Registration and Evaluation Evidence System and the value of orientation of the “personal experience”

Abstract

Traditional Chinese Medicine (TCM), as a treasure of the Chinese nation, plays a significant role in maintaining public health. In 2019, the Central Committee of the Communist Party of China and the State Council proposed for the first time the establishment of a TCM registration and evaluation evidence system that integrates TCM theory, personal experience and clinical trials (referred to as the “Three-in-One” System) to promote the inheritance and innovation of TCM. Subsequently, the National Medical Products Administration issued several guiding principles to advance the improvement and implementation of this system. Owing to the complexity of its implementation, there are still differing understandings within the TCM industry regarding the positioning of the “Three-in-One” Registration and Evaluation Evidence System, as well as the connotation and value orientation of the “personal experience.” To address this, Academician Qi Wang, President of the TCM Association, China International Exchange and Promotion Association for Medical and Healthcare and TCM master, led a group of academicians, TCM masters, TCM pharmacology experts and clinical TCM experts to convene a “Seminar on Promoting the Implementation of the ‘Three-in-One’ Registration and Evaluation Evidence System for Chinese Medicinals.” Through extensive discussions, an expert consensus was formed, clarifying the different roles of the TCM theory, “personal experience” and clinical trials within the system. It was further emphasized that the “personal experience” is the core of this system, and its data should be derived from clinical practice scenarios. In the future, the improvement of this system will require collaborative efforts across multiple fields to promote the high-quality development of the Chinese medicinal industry.

Keywords

“Three-in-One” / personal experience / clinical trials / expert consensus

References

[1] Xinhua News Agency. Central Committee of the Communist Party of China and State Council’s opinions on promoting the inheritance and innovation of traditional Chinese medicine. https://www.gov.cn/zhengce/2019-10/26/content_5445336.htm. Issued October 26, 2019. Accessed February 19, 2025.

[2] National Medical Products Administration. Implementation opinions on promoting the inheritance and innovation of traditional Chinese medicinals. https://www.gov.cn/zhengce/zhengceku/2020-12/26/content_5573463.htm. Issued December 21, 2020. Accessed February 19, 2025.

[3] Lei Y. Academician’s Opinion, Qi Wang: From “mice nodding” to “human nodding” traditional Chinese medicinals enter a new era of drug development. https://m.cnr.cn/chanjing/health/20230721/t20230721_526338256.html. Published July 21, 2023. Accessed February 19, 2025. . 2023. Accessed February 19, 2025.

[4] Center for Drug Evaluation NMPA. Information disclosure. https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c. Accessed February 19, 2025.

[5] China Association of Chinese Medicine. Top 10 academic progress in traditional Chinese medicine in 2022. Chin J Exp Tradit Med Formulae. 2023; 29(15):179-198.

[6] Center for Drug Evaluation, NMPA. Notice on releasing the “Technical Guiding Principles for Benefit-Risk Assessment of New Drugs” by the Center for Drug Evaluation, National Medical Products Administration. https://www.cde.org.cn/main/news/viewInfoCommon/cf70af12d88f6068a9fcbb11b7d8db6b. Issued June 20, 2023. Accessed February 19, 2025. 2023. Accessed February 19, 2025.

[7] Center for Drug Evaluation, NMPA. Notice on releasing the “Clinical Value-Oriented Guidelines for Anticancer Drug Clinical Development” by the Center for Drug Evaluation, National Medical Products Administration. https://www.cde.org.cn/main/news/viewInfoCommon/ef7bfde96c769308ad080bb7ab2f538e. Issued November 15, 2021. Accessed February 19, 2025. 2021. Accessed February 19, 2025.

[8] Center for Drug Evaluation, NMPA. Notice on releasing the “Guiding Principles for the Clinical Development of New Chinese Medicinal Compound Preparations Based on Personal Experience (Trial)” and “Guidelines for Communication Based on the Three-in-One Registration and Evaluation Evidence System (Trial)” by the Center for Drug Evaluation, National Medical Products Administration. https://www.cde.org.cn/main/news/viewInfoCommon/8a1682a8d37494732f7f441dd11f5af6. Issued April 29, 2022. Accessed February 19, 2025.

[9] Che QZ, Tong L, Zhang HM, et al. Key design points for further clinical studies based on personal experience in the development of new traditional Chinese medicinals. J Basic Chin Med. 2024; 30(9):1495-1499.

[10] National Medical Products Administration. Notice on the releasing the “Special Regulations on the Registration and Management of Chinese Medicinals” by the National Medical Products Administration. https://www.gov.cn/zhengce/zhengceku/2023-02/15/content_5741583.htm. Issued February 10, 2023. Accessed February19, 2025.

[11] Center for Drug Evaluation, NMPA. Notice on releasing the “Guiding Principles for Generating Real-World Evidence Using Real-World Data (Trial) by the Center for Drug Evaluation, National Medical Products Administration. https://www.cde.org.cn/main/news/viewInfoCommon/2a1c437ed54e7b838a7e86f4ac21c539. Issued April 13, 2021. Accessed February 19, 2025.