省级中药饮片炮制规范法律属性探析

Discussion on the legal attributes of provincial Chinese herbal pieces processing norms

目的为省级中药饮片炮制规范法律地位的明确以及《药品管理法》中“药品标准”法律表述的立法技术完善提供参考。方法结合我国药品地方标准法律渊源,对中药饮片国家药品标准构成要件以及现行省级中药饮片炮制规范构成进行分析,同时基于法律解释的方法,对《药品管理法》中省级中药饮片炮制规范的法律内涵进行探讨。结果与结论在药品监管实务中,省级中药饮片炮制规范实质为地方药品标准,2019年新修订的《药品管理法》对药品标准进行了专门规定,但对于省级中药饮片炮制规范的药品标准法律属性并未作出规定,存在一定的立法技术瑕疵。建议在《药品管理法》修正时,对省级中药饮片炮制规范的药品标准法律属性予以明确。

OBJECTIVE To provide a reference for the definition of the legal attributes of the provincial Chinese herbal pieces processing norms and the improvement of legal expression for the drug standards in Drug Administration Law.METHODS Based on the legal evolution of local drug standards in China,the composition of national drug standards for Chinese herbal pieces and the composition of current provincial Chinese herbal pieces processing norms were analyzed;at the same time,based on the method of legal interpretation,the legal connotation of the provincial Chinese herbal medicine processing norms in Drug Administration Law was investigated.RESULTS&CONCLUSIONS In the practice of drug supervision,the provincial Chinese herbal pieces processing norms are essentially local drug standards.The newly revised Drug Administration Law defines the drug standards specifically,but does not stipulate the legal attribute of drug standards for the provincial Chinese herbal pieces processing norms,and there are certain legislative technical defects.It is suggested that when amending the Drug Administration Law,the legal attributes of the drug standards of the provincial Chinese herbal medicine processing norms should be clarified.