Discussion on the legal attributes of provincial Chinese herbal pieces processing norms
- VernacularTitle:省级中药饮片炮制规范法律属性探析
- Author:
Heyun NIE
1
,
2
;
Haowei SONG
3
;
Weifeng ZHU
4
;
Ming XIE
2
;
Minxian SONG
4
Author Information
1. Pharmaceutical Supervision Science Research Base of Jiangxi Province，Jiangxi University of Chinese Medicine，Nanchang 330004，China
2. College of Pharmacy，Liaoning University of Traditional Chinese Medicine，Liaoning Dalian 116600，China
3. Beijing Dongwei （Chengdu） Law Firm，Chengdu 610065，China
4. Key Laboratory of Modern Preparations of Traditional Chinese Medicine，Ministry of Education，Jiangxi University of Chinese Medicine，Nanchang 330004，China
- Publication Type:Journal Article
- Keywords:
Chinese herbal pieces;
provincial;
processing norms;
drug standard;
legal attribute
- From:
China Pharmacy
2024;35(5):513-517
- CountryChina
- Language:Chinese
-
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.
