Research and development strategies of new Chinese medicines based on new regulations.
10.19540/j.cnki.cjcmm.20210224.603
- Author:
Ting WANG
1
;
Hong-Mei LIN
1
;
Jiang-Yong YU
2
;
Gang ZHOU
3
;
Yue-Hua ZHOU
3
;
Jian-Yuan TANG
4
;
Lin ZHANG
1
;
Yan-Tong XU
1
Author Information
1. Beijing Research Institute of Chinese Medicine, Beijing University of Chinese Medicine Beijing 100029, China National Medical Products Administration Key Laboratory for Research and Evaluation of Traditional Chinese Medicine Beijing 100029, China.
2. Department of Drug Registration (Department of Traditional Chinese Medicines and Ethno-Medicines Supervision), National Medical Products Administration Beijing 100037, China.
3. Center for Drug Evaluation, National Medical Products Administration Beijing 100022, China.
4. Affiliated Hospital of Chengdu University of Traditional Chinese Medicine Chengdu 610075, China.
- Publication Type:Journal Article
- Keywords:
clinical value;
medication experience on human body;
new Chinese medicines;
research and development strategies
- MeSH:
China;
Drugs, Chinese Herbal;
Medicine, Chinese Traditional;
Pharmaceutical Preparations;
Research
- From:
China Journal of Chinese Materia Medica
2021;46(12):3150-3155
- CountryChina
- Language:Chinese
-
Abstract:
In recent years, only a small number of new Chinese medicines have been approved for marketing, which has embodied the bottleneck in the development of the Chinese medicine industry. To tackle this problem, the National Medical Products Administration has issued a series of regulations and technical requirements. In the context of new regulations, this study deeply explored the research and development strategies of new Chinese medicines under the guidance of the new classification of drug registration, and discussed the key technical issues in the research and development.
