Communication in process of R&D and registration of new drugs of traditional Chinese medicine.
10.19540/j.cnki.cjcmm.20201210.601
- Author:
Ling HAN
1
;
Chen-Chen HOU
1
Author Information
1. Center for Drug Evaluation, National Medical Products Administration Beijing 100022, China.
- Publication Type:Journal Article
- Keywords:
R&D;
communication;
new drugs of traditional Chinese medicine;
registration
- MeSH:
Communication;
Drugs, Chinese Herbal;
Medicine, Chinese Traditional;
Pharmaceutical Preparations
- From:
China Journal of Chinese Materia Medica
2021;46(3):730-735
- CountryChina
- Language:Chinese
-
Abstract:
In recent years, the National Medical Products Administration has established a communication system for the process of drug R&D and registration. In this paper, the reform policies on establishing the communication system for drug evaluation in recent years were summarized, and the channels, processes, methods and types of communication were also collected. In addition, the communication status of new drugs of traditional Chinese medicine(TCM) was summarized according to the whole process of R&D, including summary of clinical practice, Investigational New Drug Applications, period of clinical trials, New Drug Applications, and post-marketing researches. Meanwhile, the current problems such as ineffective, inefficient, repeated or even no communication were analyzed, and relevant suggestions were proposed accordingly in order to provide reference for better communication on R&D and registration of new drugs of TCM.
