NIE Heyun, SONG Minxian, YAN Guiping, et al. Analysis on the expression of drug standards and related issues in the newly revised Drug Administration Law[J]. China Pharmacy, 2022,33(15).
NIE Heyun, SONG Minxian, YAN Guiping, et al. Analysis on the expression of drug standards and related issues in the newly revised Drug Administration Law[J]. China Pharmacy, 2022,33(15).DOI:
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.
关键词
药品管理法药品标准药品注册标准表述条款中药饮片
Keywords
Drug Administration Lawdrug standarddrug registration standardexpressionprovisionsChinese herbal pieces