Formulation of technical guidelines in line with characteristics and principles of traditional Chinese medicine changes to improve quality of such preparations--interpretation of Technical guidelines for the study of pharmaceutical changes in traditional Chinese medicines.
10.19540/j.cnki.cjcmm.20210402.601
- Author:
Chang-Ming YANG
1
;
Wei ZHAO
1
;
Jian-Bo QU
1
;
Si-Yuan ZHOU
1
Author Information
1. Center for Drug Evaluation, National Medical Products Administration Beijing
- Publication Type:Journal Article
- Keywords:
Technical guidelines for the study of pharmaceutical changes in traditional Chinese medicines;
secondary development;
study of pharmaceutical changes
- MeSH:
Consensus;
Drug Compounding;
Drugs, Chinese Herbal;
Medicine, Chinese Traditional;
Pharmaceutical Preparations;
Quality Improvement
- From:
China Journal of Chinese Materia Medica
2021;46(8):2016-2019
- CountryChina
- Language:Chinese
-
Abstract:
In leading the high-quality development of Chinese medicine preparations, it is an important link to formulate the scientific, reasonable, and feasible guidelines for the change of Chinese medicines in accordance with the change characteristics and principles of the Chinese medicines is an important work to promote the Technical guidelines for the study of pharmaceutical changes in traditional Chinese medicines was formed by a broad consensus based on the characteristics and research results of the pharmaceutical changes in Traditional Chinese Medicines(TCM)with the principles of science and risk management. This guideline has clarified the basic principles and requirements for the evaluation of changes in TCM, specified the research and verification work of common change scenarios, defined the boundaries of changes in TCM, and proposed to encourage the use of new technologies, new methods, and new excipients that meet product characteristics. It will definitely promote the quality improvement and the secondary development of TCM. In this article, the revision background and main content of the guideline were introduced, and the main features of the Guideline were analyzed, in order to provide references for the industry.
