Study on Formation Mechanism of National Drug Standards Based on Standard Investigation of Traditional Chinese Medicine Dispensing Granules
10.13422/j.cnki.syfjx.20200854
- VernacularTitle:从中药配方颗粒标准研究探讨国家药品标准形成机制
- Author:
Zong-hua SONG
1
;
Hai-nan WANG
2
;
Li-xin WANG
3
;
Zhong-zhi QIAN
1
;
Li-wei YANG
3
Author Information
1. Chinese Pharmacopoeia Commission, Beijing 100061, China
2. National Medical Products Administration, Beijing 100053, China
3. Center for Certification＆Evaluation, Jiangsu Food and Drug Administration, Nanjing 210001, China
- Publication Type:Research Article
- Keywords:
streamline administration, delegate powers, and improve regulation and services;
traditional Chinese medicine dispensing granules(TCMDG);
national drug standards;
formation mechanism;
pilot production;
standard decoction;
evaluation indexes
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2020;26(13):206-211
- CountryChina
- Language:Chinese
-
Abstract:
This paper, taking the formulation of national drug standards for traditional Chinese medicine (TCM) dispensing granules as a case study, explores the improvement of the formation mechanism of national drug standards, and promotes the reform of streamline administration, delegate powers, and improve regulation and services of national standards management, so as to release the vitality of the research and development of standards of drug manufacturers. After nearly two decades of pilot production of TCM dispensing granules, a large number of researches and discussions have been conducted on the formulation of unified standards of TCM dispensing granules from manufacturing enterprises to national standard administration departments, it was found that this work was difficult on the basis of the original drug standard formation mechanism. The authors tried to improve and innovate the formation mechanism of national drug standards, to provide methods and ideas for the formulation and unification of national standards for TCM dispensing granules, and to provide references for the formulation of other national drug standards.
