Wanko Richard, Unkelbach Uwe
European Directorate for the Quality of Medicines & HealthCare (EDQM), Europarat, 7 allée Kastner, CS30026, 67081, Straßburg, Frankreich.
Paul Ehrlich Institut, Paul-Ehrlich-Straße 51-59, 63225, Langen, Deutschland.
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2017 Nov;60(11):1221-1227. doi: 10.1007/s00103-017-2625-7.
Official medicines control laboratories (OMCLs) have for a long time been involved in testing activities related to suspected counterfeit or other illegal medicines in a number of European countries in support of national enforcement authorities. With the secretarial support of the European Directorate for the Quality of Medicines & HealthCare (EDQM), from 2005 onwards, the General European OMCL Network (GEON) has gradually introduced for its members tailored tools, joint test programmes and information/discussion platforms in the field of falsified medicines testing. Since 2011 a dedicated OMCL working group (OMCL Counterfeit/Illegal Medicines Working Group) has taken the lead in coordinating the different activities, which range from training programmes, symposia and focus topics at annual meetings to the development and improvement of databases and the drafting of common documents. The overall goal of these activities is to share know-how, to establish and identify centres of expertise, to further develop competencies in the field of analysis of falsified medicines, to challenge the competency of OMCLs in the testing of unknown samples, to raise awareness of the network and to leverage synergies in particular with respect to this field of expertise. All these measures aim at strengthening the network in the combat against falsified medicines, enlarging the field of activities of the OMCLs in this area and improving the hit rate with respect to the identification of adulterations.
长期以来,官方药品控制实验室(OMCLs)一直在一些欧洲国家参与与疑似假冒或其他非法药品相关的检测活动,以支持国家执法当局。在欧洲药品与医疗保健质量理事会(EDQM)的秘书支持下,自2005年起,欧洲OMCL总网络(GEON)逐渐为其成员引入了假药检测领域的定制工具、联合检测计划以及信息/讨论平台。自2011年起,一个专门的OMCL工作组(OMCL假冒/非法药品工作组)牵头协调各项不同活动,这些活动涵盖培训计划、研讨会、年会重点议题,以及数据库的开发与完善和共同文件的起草。这些活动的总体目标是分享专业知识,建立和确定专业中心,进一步发展假药分析领域的能力,检验OMCLs在未知样品检测方面的能力,提高网络的知名度,并特别是在这一专业领域发挥协同作用。所有这些措施旨在加强该网络打击假药的力度,扩大OMCLs在这一领域的活动范围,并提高掺假识别的命中率。