首页|对《药品管理法》中药饮片不符合药品标准尚不影响安全性和有效性条款的探讨

对《药品管理法》中药饮片不符合药品标准尚不影响安全性和有效性条款的探讨

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考虑到中药饮片的特殊性,《药品管理法》第一百一十七条第二款对中药饮片不符合标准,尚不影响安全性、有效性的情形作出特殊规定。本文将针对《药品管理法》第一百一十七条第二款相关指导文件的制定情况,围绕中药饮片不符合药品标准尚不影响安全性和有效性的适用情形、风险研判及企业召回规定,结合处罚依据,分析、探讨该条款的行政处罚司法案件,以期为严格规范执法、促进执法统一提供借鉴。
Discussion on provisions of Drug Administration Law on Chinese herbal pieces not conforming to drug standards without affecting safety and effectiveness
Considering the special characteristics of traditional Chinese herbal pieces,Article 117(2)of the Drug Administration Law provides special provisions for situations where traditional Chinese herbal pieces do not meet the standards and do not yet affect the safety and efficacy.This article will focus on the development of guidance documents related to Article 117(2)of the Drug Administration Law,surrounding the applicable circumstances of non-compliance with drug standards for traditional Chinese herbal pieces that do not yet affect safety and efficacy,risk assessment and enterprise recall provisions,in conjunction with the provisions of the penalty basis to analysis and discuss judicial cases of administrative penalties,so as to provide reference for strict standardized law enforcement and promote uniform law enforcement.

Chinese materia medica preparationherbal pieces for decoctionsafetytreatment outcomeDrug Administration Law

梁云、李鑫悦、罗赛男、蒋蓉

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广东省药品监督管理局,广东广州 510080

中国药科大学药品监管科学研究院,江苏南京 211198

广东食品药品职业学院,广东广州 510520

中药制剂 饮片 安全 治疗结果 药品管理法

2024

中国新药与临床杂志
中国药学会 上海市食品药品监督管理局科技情报研究所

中国新药与临床杂志

CSTPCD北大核心
影响因子:0.967
ISSN:1007-7669
年,卷(期):2024.43(1)
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