药品应急检验管理的探索性研究

发布时间：2018-11-18 12:33

【摘要】：目的提升我国药品应急检验的管理水平,为药品安全突发事件的处置提供新思路。方法对我国药品应急检验的管理历程进行梳理,对近年来典型药品应急检验事件的应对思路进行分析,对国外发达国家的相关经验进行研究。结果我国药品应急检验经历了管理机制从无到有、应对机构从点到面的过程,应急之网虽已基本建立,但各环节均有不足。课题组依据典型案例分析结果,并结合发达国家的经验,制定了一系列的措施加强管理。结论笔者将理论与实践相结合,形成独特的解决思路图,并提出4条针对措施,具有创新性。第一,提出全系统的管理预案,使药检系统形成合力,扭转单兵作战的现状;第二,提出应急检验技术预案,为检验时查找药害的原因提供合理路径图;第三,提出4条加强技术储备的有效措施,为管理预案与技术预案提供必要的辅助资源;第四,提出政府监管策略和企业防范策略,争取从源头防范。以上措施,将显著增强我国对药品安全突发事件的应急管理能力。
[Abstract]:Objective to improve the management level of drug emergency inspection in China, and to provide a new way to deal with drug safety emergencies. Methods the management course of drug emergency inspection in China was combed out, the countermeasures of typical drug emergency inspection events in recent years were analyzed, and the relevant experiences of foreign developed countries were studied. Results the emergency inspection of drugs in our country has experienced the process of management mechanism from nothing to existence, and the emergency network has been basically established, but all the links are deficient in the process of dealing with the mechanism from point to face. According to the analysis of typical cases and the experience of developed countries, a series of measures are put forward to strengthen management. Conclusion the author combines theory with practice to form a unique solution plan and puts forward four measures which are innovative. First, put forward the management plan of the whole system, make the drug inspection system form the joint force, reverse the current situation of single combat, second, put forward the emergency inspection technology plan, provide the reasonable path map for finding out the reason of the drug damage during the inspection. Third, four effective measures to strengthen the technical reserve are put forward to provide the necessary auxiliary resources for the management of the preparatory plan and the technical plan, and the fourth, the government supervision strategy and the enterprise prevention strategy are put forward to prevent from the source. The above measures will significantly enhance the ability of emergency management of drug safety emergencies in China.
【作者单位】：中国食品药品检定研究院;
【分类号】：R954

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