摘要
目的旨在通过对新修订《药品质量抽查检验管理办法》的分析和探讨,提出可行的应对举措和建议,推动药品抽检管理模式的创新。方法基于风险管理理念,结合药品抽查检验工作中的实际问题,对《药品质量抽查检验管理办法》中相关条款的要求进行分析和梳理,对加强国家药品抽检中的风险管理工作提出建议和对策。结果与结论《药品质量抽查检验管理办法》中包括了风险评估、风险控制和风险沟通和审核三个方面的多个条款,药品监督管理部门应该组织开展技术分析和研判,发现抽检品种可能存在的风险信号,并根据风险评估结果采取相应的风险控制和监管措施,并对有关工作情况进行信息公开。
Objective To put forward some feasible countermeasures and suggestions through the analysis and discussion of the newly revised"regulations for drug quality sampling and testing"so as to promote the innovation of the management mode of drug sampling inspection.Methods Based on the concept of risk management,combined with the problems in drug quality sampling and testing,the requirements of the relevant provisions in the newly revised regulations were analyzed,then some suggestions and countermeasures on improving drug sampling test in the new period were proposed.Results and conclusions Drug quality random inspection is one of the important means of post-market drug supervision.The drug supervision and management department should carry out technical analysis to discover the possible risk signals of random inspection varieties,and then it can take corresponding risks control measures based on the results of risk assessment.Finally,the relevant work information can be made public.
作者
朱嘉亮
郗昊
胡骏
李哲媛
杨悦
朱炯
ZHU Jialiang;XI Hao;HU Jun;LI Zheyuan;YANG Yue;ZHU Jiong(National Institutes for Food and Drug Control,Beijing 102629,China;Shanghai Institute for Food and Drug Safety;Yunnan Institute for Food and Drug Control,Kunming 650106;Institute of Drug Regulatory Sciences,Shenyang Pharmaceutical University,Shenyang 110016,China)
出处
《沈阳药科大学学报》
CAS
CSCD
北大核心
2020年第9期827-832,共6页
Journal of Shenyang Pharmaceutical University
关键词
药品
抽查检验
风险管理
Drug
quality sampling and testing
Risk management
