药品复验申请的审核要点研究
发布时间：2018-12-10 07:19
【摘要】：药品复验即药品仲裁检验,是中国食品药品检定研究院(简称中检院)的基本职能之一;作为我国药品检验的最高仲裁机构,中检院的服务面广,受理复验申请的范围不仅包括国家级承检药品,也包括省市级药品检验机构所承检的药品,法律意义重大。中检院药品检验处作为药品复验申请的审核部门,在对相关法规仔细研究的基础上,结合实践经验,形成了5步工作程序,在有效减轻业务科室无谓工作量的同时,保持了零投诉,部分举措被国家食品药品监督管理总局在修订规章时采纳。本文通过对多年申请情况进行研究,分析审核中存在的难点与争议点,并提出解决对策,力争从源头把关,有效地提高药品复验管理的工作效率,也提升监管部门的公信力。
[Abstract]:Drug reinspection is one of the basic functions of the Chinese Institute for Food and Drug Control (CCPDA). As the highest arbitration institution of drug inspection in our country, the scope of service is wide. The scope of accepting the application for reinspection includes not only the national drug subject, but also the drug accepted by the provincial and municipal drug inspection agencies, which is of great legal significance. On the basis of careful study of relevant laws and regulations and combined with practical experience, the Drug Inspection Office of the Central Inspection Institute, as the examination department for drug re-inspection applications, has formed a five-step working procedure, which effectively reduces the unnecessary workload of the business departments at the same time. Zero complaints were maintained, and some of the measures were adopted by the State Food and Drug Administration when revising the regulations. Through the research on the application situation for many years, this paper analyzes the difficulties and controversies existing in the examination and verification, and puts forward some countermeasures to solve the problem, so as to effectively improve the efficiency of drug re-inspection management and enhance the credibility of the supervision department.
【作者单位】： 中国食品药品检定研究院;
【分类号】：R95;F203
[Abstract]:Drug reinspection is one of the basic functions of the Chinese Institute for Food and Drug Control (CCPDA). As the highest arbitration institution of drug inspection in our country, the scope of service is wide. The scope of accepting the application for reinspection includes not only the national drug subject, but also the drug accepted by the provincial and municipal drug inspection agencies, which is of great legal significance. On the basis of careful study of relevant laws and regulations and combined with practical experience, the Drug Inspection Office of the Central Inspection Institute, as the examination department for drug re-inspection applications, has formed a five-step working procedure, which effectively reduces the unnecessary workload of the business departments at the same time. Zero complaints were maintained, and some of the measures were adopted by the State Food and Drug Administration when revising the regulations. Through the research on the application situation for many years, this paper analyzes the difficulties and controversies existing in the examination and verification, and puts forward some countermeasures to solve the problem, so as to effectively improve the efficiency of drug re-inspection management and enhance the credibility of the supervision department.
【作者单位】： 中国食品药品检定研究院;
【分类号】：R95;F203
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