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.