First experiences with the implementation of EU Regulation 536/2014 (CTR) from the perspective of non-commercial academic research

Abstract

With the implementation of the new EU Regulation 536/2014 (Clinical Trials Regulation – CTR) on 31 January 2022, the approval and conduct of clinical trials with medicinal products for human use are to be harmonized within the European Union (EU). Approval is granted via the electronic Clinical Trials Information System (CTIS) portal of the European Medicines Agency (EMA). In addition to commercial sponsors, sponsors at academic institutions are also affected by the implementation of the CTR in the context of investigator-initiated clinical trials (IITs). Numerous changes in the process map for regulated drug trials are necessary. New aspects concern the general user structure and the role and permission concept of CTIS. Requirements that previously applied only to investigational medicinal products/placebo now also apply to auxiliary medicinal products. Investigational and auxiliary medicinal products not yet approved in the EU must be registered in the XEVMPD drug database. Other significant changes include the reporting of “serious breaches,” the publication of relevant study documents, the introduction of a “summary in layman’s terms,” the archiving period of 25 years, the implementation of “low intervention clinical trials,” and the possibility of co-sponsorship. First experience with the application process shows that the new system needs to be further improved. This concerns, for example, the EU-wide harmonization of requirements and the elimination of technical deficiencies. In the medium and long term, however, simplifications with regard to regulatory processes should be noticeable. What is needed here are intensified agreements with national higher authorities and ethics committees, effective knowledge management, and improved communication.