新修订《药品管理法》文本中药品标准表述及相关问题探析

Analysis on the expression of drug standards and related issues in the newly revised Drug Administration Law

目的对新修订《药品管理法》文本中有关药品标准表述及条款进行梳理分析,探析药品注册标准内涵及其法律定位,以期为《药品管理法》中药品标准相关条款合理适用及有权解释提供参考。方法回顾我国药品标准管理演变历程,解析《药品管理法》药品标准法律条文,采用对比及文献研究法,分析有关药品标准的法律表述与内涵。结果与结论新修订《药品管理法》现有条文中对药品标准存在“国家药品标准”“药品标准”“质量标准”等不同表述,省级中药饮片炮制规范法律定位不明确,在药品管理执法实践中可能存在法律规制不足。有必要对有关药品标准表述及条款内容进行有权解释;同时应进一步明确省级中药饮片炮制规范药品标准的法律属性,以促进中药饮片标准化管理。

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.