Stahl Elke
Abteilung Wissenschaftlicher Service, Klinische Prüfung, Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Kurt-Georg-Kiesinger Allee 3, 53175, Bonn, Deutschland.
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2017 Aug;60(8):836-840. doi: 10.1007/s00103-017-2579-9.
The upcoming Regulation EU 536/2014 for clinical trials of medicinal products for human use requires multinational cooperation in the assessment of clinical trial applications by the member states concerned as well as one single decision per member state concerned, supported by the new EU Portal and database system. The implementation makes national reorganisation of the processes necessary, especially coordination and cooperation between the national competent authorities and the ethics committees, necessary.A brief overview of implementation status with regard to national law adaptations, (re-) organisation, information technology systems as well as national or multinational pilot projects in 7 of 28 member states is given.Within these member states some national laws have been adapted already, while others will be soon. The national reorganisation covers mostly administrative organisation and coordination especially within the ethics committees. Overall, it is foreseen that a reduced number of ethics committees will be involved in the approval of clinical trials on medicinal products within the member states.Most of the seven member states expect that in addition to the new EU Portal/database system a national IT system for national cooperation and interaction will be necessary. Therefore, an interface within the EU system for national systems is essential.In order to test the new processes some member states are running national pilot projects or are planning them. In addition, almost all participate in the voluntary multinational assessment of clinical trials on medicinal products, which had existed since 2009, a few also in cooperation with their ethics committees.The member states are confident that all national processes will be in place when the EU regulation becomes applicable.
即将出台的欧盟第536/2014号法规针对人用药品临床试验，要求相关成员国在评估临床试验申请时开展跨国合作，并在新的欧盟门户和数据库系统的支持下，各相关成员国做出单一决定。这一实施使得各国必须对流程进行重新组织，尤其是国家主管当局与伦理委员会之间的协调与合作。本文简要概述了28个成员国中的7个国家在国家法律调整、（重新）组织、信息技术系统以及国家或跨国试点项目方面的实施状况。在这些成员国中，一些国家的法律已经进行了调整，而其他国家也将很快进行调整。国家层面的重新组织主要涉及行政组织和协调，尤其是在伦理委员会内部。总体而言，可以预见，参与成员国药品临床试验审批的伦理委员会数量将会减少。这七个成员国中的大多数预计，除了新的欧盟门户/数据库系统外，还需要一个用于国家合作与互动的国家信息技术系统。因此，欧盟系统内用于连接国家系统的接口至关重要。为了测试新流程，一些成员国正在开展或计划开展国家试点项目。此外，几乎所有成员国都参与了自2009年以来就存在的药品临床试验自愿跨国评估，少数成员国还与本国的伦理委员会合作。成员国相信，当欧盟法规适用时，所有国家流程都将就绪。
