Thoughts on path of R&D and registration of innovative traditional Chinese medicine with synchronous transformation of "series prescriptions".
10.19540/j.cnki.cjcmm.20211027.501
- Author:
Yan-Ling AI
1
;
Jian-Yuan TANG
1
;
Gang ZHOU
2
;
Lei ZHANG
3
;
Li-Ping QU
4
;
Shi-Yao HUANG
1
;
Zhong-Qi YANG
5
;
Wei-An YUAN
6
;
Yue-Hua ZHOU
2
;
Ting WANG
7
;
Jun-Ning ZHAO
8
;
Xiao-Bo SUN
9
;
Xiao-He XIAO
10
;
Zi-Feng YANG
11
;
Qing-Quan LIU
12
;
Ming-Jun ZHU
13
;
Xiang-Yang LENG
14
;
Chun-Guang XIE
1
;
Song-Yan CHAI
12
Author Information
1. Hospital of Chengdu University of Traditional Chinese Medicine Chengdu 610075, China.
2. Center for Drug Evaluation,National Medical Products Administration Beijing 100022, China.
3. Shanghai University of Traditional Chinese Medicine Shanghai 201203, China.
4. State Key Laboratory of Southwestern Chinese Medicine Resources, Chengdu University of Traditional Chinese Medicine Chengdu 610037, China.
5. the First Affiliated Hospital of Guangzhou University of Chinese Medicine Guangzhou 510405, China.
6. Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine Shanghai 201203, China.
7. Beijing University of Chinese Medicine Beijing 100029, China.
8. State Key Laboratory of Quality Evaluation of Traditional Chinese Medicine, Natiorcal Administration of Traditional Chinese Medicine, Sichuan Academy of Traditional Chinese Medicine Chengdu 610041, China.
9. Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences, Peking Union Medical College Beijing 100094, China.
10. Department of China Military Institute of Chinese Materia, the Fifth Medical Center, Chinese PLA (People's Liberation Army) General Hospital Beijing 100039, China.
11. State Key Laboratory of Respiratory Diseases,Guangzhou Medical University Guangzhou 510180, China.
12. Beijing Traditional Chinese Medicine Hospital,Capital Medical University Beijing 100010, China.
13. the First Affiliated Hospital of Henan University of Chinese Medicine Zhengzhou 450099, China.
14. Changchun University of Chinese Medicine Changchun 130117, China.
- Publication Type:Journal Article
- Keywords:
R&D and registration;
new drugs of traditional Chinese medicine;
series prescription;
synchronous transformation
- MeSH:
China;
Drugs, Chinese Herbal/therapeutic use*;
Medicine, Chinese Traditional;
Prescriptions;
Public Health
- From:
China Journal of Chinese Materia Medica
2022;47(4):1120-1125
- CountryChina
- Language:Chinese
-
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.
