浅析新修订《药品管理法》假药劣药规定的变化及其对认定检验带来的影响  

Analysis of Changes to Provisions on Counterfeit and Substandard Drugs in the Newly-revised Drug Administration Law and the Impact on testing

作　　者：董红环 杨玥莹 高芳[1] 梁静 黄清泉[1] DONG Hong-huan;YANG Yue-ying;GAO Fang;LIANG Jing;HUANG Qing-quan(National Institutes for Food and Drug Control)

机构地区：[1]中国食品药品检定研究院

出　　处：《中国食品药品监管》2021年第5期90-97,共8页China Food & Drug Administration Magazine

摘　　要：目的:针对新修订《药品管理法》假药劣药相关规定的变化,分析其对认定检验带来的影响并提出应对措施。方法:系统对比新旧《药品管理法》在假药劣药范围定义、处罚力度和认定原则等方面的差异,讨论其给药品检验机构假药劣药认定检验带来的影响,并结合实际工作经验提出应对这种变化的建议。结果和讨论:本文结合实际工作经验,从提高检验质量和检验效率两个角度提出可行方案,希望能为顺利应对新修订《药品管理法》假药劣药相关规定的变化提供参考。Objectives:In view of the changes of the relevant provisions on counterfeit and substandard drugs in the newlyrevised Drug Administration Law,this paper analyzed the impact on the identification and testing,and provided some suggestions.Methods:Based on comparisons between the previous and current versions of Drug Administration Law with respect to the definition,punishment and verification principles of counterfeit and substandard drugs,this paper discussed the effects of these changes on the identification and testing of counterfeit and substandard drugs,and proposed some suggestions to deal with this change based on practical work experience.Results and Discussion:based on practical work experience,this paper proposed feasible solutions from the perspective of improving the quality and efficiency of testing,hoping to provide a reference for the response to the changes of the relevant provisions on counterfeit and substandard drugs in the newly-revised Drug Administration Law.

关 键 词：药品管理法 假药劣药 认定检验 药品检验机构 检验依据 

分 类 号：R95[医药卫生—药学]