[Evaluation of clinical trials on medicinal products by ethics committees: changes due to the new EU Regulation 536/2014 (CTR) and necessary harmonization measures]. / Bewertung klinischer Arzneimittelprüfungen durch Ethikkommissionen: Änderungen durch die neue EU-Verordnung 536/2014 (CTR) und nötige Harmonisierungsmaßnahmen.

ABSTRACT

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. The harmonization efforts of the ethics committees at the EU level are discussed.According to the new EU regulation, only one ethics committee is involved in the approval of a clinical trial of medicinal products in Germany. The previous consultation procedure involving several locally competent ethics committees has been replaced. Instead, there is now closer cooperation between the ethics committees and the federal authorities through the preparation of a joint assessment report as well as with the other EU member states as part of the consolidation of the respective country-specific requirements. The regular mutual exchange between the ethics committees that had previously accompanied the consultation procedure helped to harmonize the decision criteria but also the discretionary decisions. Due to the discontinuation of this exchange, more detailed procedural recommendations are required but also other regular exchange possibilities in order to not only maintain but also to advance harmonizations already in place. The Working Group of Medical Ethics Committees (AKEK), as the representative of the individual ethics committees, also maintains an intensive exchange with federal authorities, applicants, other European ethics committees and European institutions.