[The new approval procedure for clinical trials of medicinal products in the European Union-challenges for the pharmaceutical industry in Germany]

Abstract

In the European Union (EU), 27 May 2014 was a significant date for clinical trials. Since that day, the EU Clinical Trials Regulation 536/2014 (EU-CTR) officially came into force. The new EU-CTR replaces EU Directive 2001/20/EC and fundamentally reforms the way clinical trials are applied for and conducted in Europe. For clinical trial sponsors, the responsible regulatory authorities, ethics committees, and all EU member states, the new EU-CTR brings profound changes. However, it has taken a long time for the new regulation to be applied, as the establishment of the new Clinical Trials Information System (CTIS) of the European Medicines Agency (EMA) has taken some time. Contrary to expectations, the establishment of this system could not be completed in 2016, but only with a notification from the EMA on 31 July 2021.Overall, Germany is well prepared for the new regulation. The German Medicinal Products Act (AMG) was adjusted at an early stage. Authorities and ethics committees have tested the cooperation in a pilot phase from 2015 to 2021 and have shown that the cooperation in Germany works well in the evaluation of applications.However, initial experience from the application process shows that there are some fundamental problems with CTIS and that there is also a need for further adaptation at the national level in Germany. This includes, for example, the integration of the Federal Office for Radiation Protection (BfS) approval or the harmonization of ethics committee requirements. It is important that Germany addresses these points at the national level to remain competitive.

Keywords: Clinical Trials; EU Clinical Trials Regulation 536/2014; National implementation in the Medicinal Products Act (Arzneimittelgesetz AMG); Pilot phase for preparation; Study location Germany.