Closed-loop management model of clinical investigational product for new drug of traditional Chinese medicine.
- Author:
Ping WU
1
;
Jian-Wu ZHANG
2
Author Information
1. Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China. wp2115@163.com
2. Beijing Food and Drug Administration, Beijing 100053, China.
- Publication Type:Journal Article
- MeSH:
Clinical Trials as Topic;
standards;
Drug Therapy;
Drug and Narcotic Control;
Drugs, Chinese Herbal;
standards;
therapeutic use;
Drugs, Investigational;
standards;
therapeutic use;
Humans;
Medication Therapy Management;
standards;
Medicine, Chinese Traditional
- From:
China Journal of Chinese Materia Medica
2013;38(17):2898-2900
- CountryChina
- Language:Chinese
-
Abstract:
This paper discussed the management regulations and technical requirements of clinical investigational product for new drug of traditional Chinese medicine, analyzed some common problems on the management of them, and proposed the establishment of closed-loop management model and management requirements in various aspects.
