[Main characteristics of the new authorisation procedure for clinical trials with medicinal products according to regulation (EU) no 536/2014 and the cooperation between the member states]

Abstract

With Regulation (EU) No. 536/2014 on clinical trials on medicinal products for human use, which became applicable on 31 January 2022, full harmonisation of the authorisation and monitoring procedures of clinical trials with medicinal products in the European Union (EU) and the European Economic Area (EEA) has been achieved. In addition to an entirely paperless application procedure, communication between all parties involved is done through the Clinical Trials Information System (CTIS), which was developed specifically for the Regulation and through which all non-proprietary information and content of the clinical trial application and results are also made available to the public. As was already the case under the old legal framework, the authorisation of a clinical trial is granted by each Member State concerned; however, the assessment of the common part of the dossier of a clinical trial that is conducted in more than one Member State is jointly done by the respective Member States under the coordinating lead of a reporting Member State. The present article outlines the authorisation procedure with its deadline concept and addresses further aspects of the Regulation, such as details on the protection of the trial subjects, safety reporting and transparency rules.

Keywords: Clinical Trials Information System (CTIS); Clinical Trials Regulation (CTR); Clinical trials on human medicinal products; Ethics committees; Pharmacovigilance.