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

NIE Heyun; SONG Haowei; ZHU Weifeng; XIE Ming; SONG Minxian

doi:10.6039/j.issn.1001-0408.2024.05.01

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

更新时间：2024-03-08

- Discussion on the legal attributes of provincial Chinese herbal pieces processing norms
- ZHONGGUO YAOFANG Vol. 35, Issue 5, Pages: 513-517(2024)
- 作者机构：
  
  1.江西中医药大学江西省药品监管科学研究基地，南昌;330004
  2.辽宁中医药大学药学院，辽宁大连　116600
  3.北京东卫（成都）律师事务所，成都　610065
  4.江西中医药大学现代中药制剂教育部重点实验室，南昌　330004
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2024.05.01
  CLC： R951
- Published：15 March 2024，
  
  Received：28 July 2023，
  
  Revised：08 December 2023，
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聂鹤云,宋浩伟,朱卫丰等.省级中药饮片炮制规范法律属性探析 ^Δ[J].中国药房,2024,35(05):513-517.

NIE Heyun,SONG Haowei,ZHU Weifeng,et al.Discussion on the legal attributes of provincial Chinese herbal pieces processing norms[J].ZHONGGUO YAOFANG,2024,35(05):513-517.
聂鹤云,宋浩伟,朱卫丰等.省级中药饮片炮制规范法律属性探析 ^Δ[J].中国药房,2024,35(05):513-517. DOI： 10.6039/j.issn.1001-0408.2024.05.01.

NIE Heyun,SONG Haowei,ZHU Weifeng,et al.Discussion on the legal attributes of provincial Chinese herbal pieces processing norms[J].ZHONGGUO YAOFANG,2024,35(05):513-517. DOI： 10.6039/j.issn.1001-0408.2024.05.01.

摘要

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。

Abstract

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.

关键词

中药饮片省级炮制规范药品标准法律属性

Keywords

provincialprocessing normsdrug standardlegal attribute

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