[Evaluation of clinical trials on medicinal products by ethics committees: changes due to the new EU Regulation 536/2014 (CTR) and necessary harmonization measures].

After Regulation (EU) No. 536/2014 (Clinical Trial Regulation, CTR) of the European Parliament and of the Council took effect on 31 January 2022, the application process for clinical trials fundamentally changed. This article describes the fundamental procedural changes and the resulting changes for Germany and, in particular, for the ethics committees.