gms | German Medical Science

The new Regulation (EU) 536/2014 on Clinical Trials (CT) will be presented and its advantages and challenges for all stakeholders, Member States and NCAs in particular, will be discussed.

The Regulation is strongly harmonising and simplifying the requirements and the approval process of (multinational) CTs for all stakeholders. The whole processes of applying, authorisation and maintenance of the complete life cycle of a CT will be managed by the use of one single portal /database for all involved parties. Therefore the implementation and functioning of the Regulation is highly bound to the crucial development of a functioning IT system by EMA. The new EU database will include all documents and even final assessment reports and will make most of the data public accessible.

The authorisation procedure is set up for all CTs, mono-national as well as multinational, with one set of documents, fixed maximum timelines, a single decision and a single payment per Member State which includes a single contact point per Member State. Member States and therefore NCAs and the independent Ethic Committees (IEC) concerned will have to work jointly. With regard to Part I of the assessment of a CTA and a substantial modification a Reporting Member State will be mainly responsible and the only contact for sponsors. Tight timelines, especially for exchange of opinions, will be one challenge and will require new structures for fast scientific communication, especially within a Member State where both NCA and IEC assess the documents.

The new concept of a joint assessment under the direction of the reporting Member State (RMS) implies stricter communication between RMS and concerned Member States (CMS). While the RMS is requested to take the CMS’ comments duly into account when preparing the assessment report the options of CMS for not following the RMS opinion are restricted to severe dissents. Additionally the Regulation allows expanding an already approved CTA to other Member States and introduces new types of CTs namely cluster trials and low intervention clinical trials. New concepts of co-sponsoring and modified rules for the protection of certain populations are also part of the Regulation followed by simplified safety reporting rules.

Overall, the new European legislation is very detailed and changes the way of communication, decision making and trial surveillance. Although immediately binding in all Member States the Regulation requires additional national legal implementations, in particular for the interaction between IECs and NCAs also in Germany.