Thoughts on path of R＆D and registration of innovative traditional Chinese medicine with synchronous transformation of "series prescriptions"Chinese Full TextEnglish Full Text (MT)
AI Yan-ling;TANG Jian-yuan;ZHOU Gang;ZHANG Lei;QU Li-ping;HUANG Shi-yao;YANG Zhong-qi;YUAN Wei-an;ZHOU Yue-hua;WANG Ting;ZHAO Jun-ning;SUN Xiao-bo;XIAO Xiao-he;YANG Zi-feng;LIU Qing-quan;ZHU Ming-jun;LENG Xiang-yang;XIE Chun-guang;CHAI Song-yan;Hospital of Chengdu University of Traditional Chinese Medicine;Center for Drug Evaluation,National Medical Products Administration;Shanghai University of Traditional Chinese Medicine;State Key Laboratory of Southwestern Chinese Medicine Resources, Chengdu University of Traditional Chinese Medicine;the First Affiliated Hospital of Guangzhou University of Chinese Medicine;Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine;Beijing University of Chinese Medicine;State Key Laboratory of Quality Evaluation of Traditional Chinese Medicine, Natiorcal Administration of Traditional Chinese Medicine, Sichuan Academy of Traditional Chinese Medicine;Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences, Peking Union Medical College;Department of China Military Institute of Chinese Materia, the Fifth Medical Center, Chinese PLA (People′s Liberation Army) General Hospital;State Key Laboratory of Respiratory Diseases,Guangzhou Medical University;Beijing Traditional Chinese Medicine Hospital,Capital Medical University;the First Affiliated Hospital of Henan University of Chinese Medicine;Changchun University of Chinese Medicine;
Abstract: Since the implementation of drug registration in China, the classification of Chinese medicine has greatly met the needs of public health and effectively guided the transformation, inheritance, and innovation of research achievements on traditional Chinese medicine（TCM）. In the past 30 years, the development of new Chinese medicine has followed the registration transformation model of " one prescription for single drug". This model refers to the R＆D and registration system of modern drugs, and approximates to the " law-abiding" medication method in TCM clinic, while it rarely reflects the sequential therapy of syndrome differentiation and comprehensive treatment with multiple measures. In 2017, Opinions on Deepening the Reform of Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices released by the General Office of the CPC Central Committee and the General Office of the State Council pointed out that it is necessary to " establish and improve the registration and technical evaluation system in line with the characteristics of Chinese medicine, and handle the relationship between the traditional advantages of Chinese medicine and the requirements of modern drug research". Therefore, based on the development law and characteristics of TCM, clinical thinking should be highlighted in the current technical requirements and registration system of research and development of Chinese medicine. Based on the current situation of registration supervision of Chinese medicine and the modern drug research in China, the present study analyzed limitations and deficiency of " one prescription for single drug" in the research and development of Chinese medicine. Additionally, a new type of " series prescriptions" was proposed, which was consistent with clinical thinking and clinical reality. This study is expected to contribute to the independent innovation and high-quality development of the TCM industry.
Keywords：
new drugs of traditional Chinese medicine; R＆D and registration; synchronous transformation; series prescription;
- DOI：
10.19540/j.cnki.cjcmm.20211027.501
- Series：
(E) Medicine ＆ Public Health
- Subject：
Traditional Chinese Medicinal Herbs
- Classification Code：
R288
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