On November 24th, the State Administration of Traditional Chinese Medicine announced the "Management Measures for Clinical Research of Traditional Chinese Medicine Initiated by Researchers in Medical and Health Institutions". This method aims to further standardize the management of relevant clinical research and improve the quality of research. According to the management regulations, clinical research on traditional Chinese medicine initiated by researchers refers to activities conducted by medical and health institutions under the guidance of traditional Chinese medicine theory, with people as research objects, and not for the purpose of registering drugs, medical devices (including in vitro diagnostic reagents) and other products, to study the etiology, diagnosis, treatment, rehabilitation, prognosis, prevention, control, and health maintenance of diseases. This management method consists of eight chapters and forty-nine articles, which determine the scope of application of relevant research, adhere to the main responsibility of institutions, stipulate the basic systems of scientific review, ethical review, institutional conclusion, and research information upload and disclosure of traditional Chinese medicine clinical research initiated by researchers, and clarify the regulatory mechanism for such traditional Chinese medicine clinical research. This management method also sets relevant regulations for the characteristics of traditional Chinese medicine. For example, the management regulations specify that in conducting intervention research on traditional Chinese medicine, members must include professional and technical personnel in the field of traditional Chinese medicine, and any judgments or clinical decisions related to traditional Chinese medicine during the research process should be made by them; The management measures provide clear requirements for the research foundation and institutional qualifications of characteristic intervention measures such as non pharmacological therapies in traditional Chinese medicine. (New Society)
Edit:Wang Shu Ying Responsible editor:Li Jie
Source:Xinhuanet
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