[Implementation status of Regulation EU 536/2014 in the member states]

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.