Analysis on the expression of drug standards and related issues in the newly revised Drug Administration Law
- VernacularTitle:新修订《药品管理法》文本中药品标准表述及相关问题探析
- Author:
Heyun NIE
1
,
2
;
Minxian SONG
2
;
Guiping YAN
3
;
Ming XIE
1
;
Yongmei GUAN
2
;
Dongmei YAN
2
;
Weifeng ZHU
2
Author Information
1. College of Pharmacy，Liaoning University of Traditional Chinese Medicine，Liaoning Dalian 116600，China
2. Key Laboratory of Modern Chinese Medicine Preparations of Ministry of Education，Jiangxi University of Chinese Medicine，Nanchang 330004，China
3. Dept. of Health Policy and Regulation，School of Economics and Management，Jiangxi University of Chinese Medicine，Nanchang 330004，China
- Publication Type:Journal Article
- Keywords:
Drug Administration Law;
drug standard;
drug registration standard;
expression;
provisions;
Chinese herbal pieces
- From:
China Pharmacy
2022;33(15):1806-1809
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To sort out and analyze the expression and provisions of drug standards in the text of the newly revised Drug Administration Law ，and to explore the connotation and legal positioning of drug registration standards so as to provide reference for the rational application and interpretation of relevant provisions of drug standards in Drug Administration Law . METHODS Through the review of the evolution of drug standard management in China ，the legal provisions of drug standard in the Drug Administration Law were analyzed. Comparative study and literature research methods were used to analyze the legal expression and connotation of drug standards. RESULTS & CONCLUSIONS There were different expressions about “national drug standards ”“drug standards ”and“quality standards ”in the current provisions of the newly revised Drug Administration Law ； the legal position of the provincial-level standard for the preparation of Chinese herbal pieces was not clear ，and there may be insufficient legal regulation in the enforcement of drug administration. It is necessary to make an administrative interpretation for the content of relevant drug standards and provisions ，and further clarify the legal attributes of drug standards in the processing of provincial Chinese herbal pieces in order to promote the standardized management of Chinese herbal pieces.
