[The new approval procedure for clinical trials of medicinal products in the European Union-challenges for the pharmaceutical industry in Germany]. / Das neue Genehmigungsverfahren für klinische Arzneimittelprüfungen in der Europäischen Union ­ Herausforderungen für die pharmazeutische Industrie in Deutschland.

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.

The future of monitoring in clinical research - a holistic approach: linking risk-based monitoring with quality management principles.

Since several years risk-based monitoring is the new "magic bullet" for improvement in clinical research. Lots of authors in clinical research ranging from industry and academia to authorities are keen on demonstrating better monitoring-efficiency by reducing monitoring visits, monitoring time on site, monitoring costs and so on, always arguing with the use of risk-based monitoring principles. Mostly forgotten is the fact, that the use of risk-based monitoring is only adequate if all mandatory prerequisites at site and for the monitor and the sponsor are fulfilled.Based on the relevant chapter in ICH GCP (International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use - Good Clinical Practice) this publication takes a holistic approach by identifying and describing the requirements for future monitoring and the use of risk-based monitoring. As the authors are operational managers as well as QA (Quality Assurance) experts, both aspects are represented to come up with efficient and qualitative ways of future monitoring according to ICH GCP.