Current Situation of Human Experience of Traditional Chinese Medicine and the Key Point of Ethical Review
10.12026/j.issn.1001-8565.2022.03.09
- VernacularTitle:中药人用经验的现状及伦理审查辨析要点
- Author:
Jiyin ZHOU
1
;
Qiang LIU
2
Author Information
1. National Drug Clinical Trial Institution, the Second Affiliated Hospital of Army Medical University, Chongqing 400037, China
2. Evaluation Center, World Federation of Traditional Chinese Medicine Societies, Beijing 100101, China
- Publication Type:Journal Article
- Keywords:
Traditional Chinese Medicine;
Human Experience;
Clinical Research;
Ethical Review
- From:
Chinese Medical Ethics
2024;35(3):282-289
- CountryChina
- Language:Chinese
-
Abstract:
In order to speed up the review and approval of new drugs of Traditional Chinese Medicine (TCM) in China, it is accelerating the construction of TCM registration review evidence system, which combines the theory of TCM, human experience and clinical trials, and optimizing the technical requirements for the review of and approval of new drugs of TCM based on ancient classic prescriptions, famous old Chinese medicine prescriptions, and medical institution preparations. The United States has strict requirements on the application for the marketing of herbal medicines. According to the characteristics of herbal medicines and combined with human experience, the European Union has classified registration management, reflecting the regulatory concept of inheritance and innovation. TCM has a long history of human use experience in China, its application has a scope of application, basic requirements, and it is necessary to classify and exempt the declaration materials according to the evidence grading evaluation standards. When the ethics committee reviews the research scheme of human experience of TCM, it should pay attention to the review points such as scientific basis for new drugs or prescriptions of TCM, clinical positioning, applicable population, effectiveness and safety information, research design, sample size, conflict of interest management and informed consent. Finally, Human experience is helpful to formulate the research scheme of new drugs of TCM, which can not only improve the success rate of research and development, but also reduces the cost of research and development, accelerate the marketing of new drugs of TCM, and can benefit more patients.
