Germany

Regulatory

Clinical trials in Germany are approved by the Federal Institute for Drugs and Medical Devices or the Paul-Ehrlich Institute, depending on the Investigational Product.

The Federal Institute for Drugs and Medical Devices (BfArM) is the medical device and clinical research regulatory authority in Germany. Functioning as an independent body within the Federal Ministry of Health, the BfArM deals with the authorization of drugs of medical devices based on the German Medicines Act (AMG).

The Paul-Ehrlich Institute is responsible for examining clinical trials of vaccines and biomedicines.

A positive opinion on the study must also be obtained from the responsible ethics committee.

Official links

https://www.bfarm.de
https://www.pei.de

Pharmaceutical Industry & Clinical Trials Market

Germany is one of the world’s leading locations for clinical trials. The country is a leader of R&D investment and patent application levels. Combining cutting edge-innovation, a long tradition of being the “world´s pharmacy” and a continuously growing demand for healthcare products, Germany constitutes the major European pharmaceutical market and the fourth largest worldwide. Over 30 biotechnology clusters contribute to the pharmaceutical innovation.

Medical System in Germany

The German healthcare is a dual public-private system. The sector is regulated by the Joint Federal Committee Healthcare ensuring free healthcare for all. In addition, it is possible obtain private health insurance to replace or top up state cover.

Germany spends 11.1% of annual GDP on healthcare expenditure.