In Germany a clinical trial must not be started before it is authorized by the competent higher federal authority. Depending on the type of investigational product two higher federal authorities with different responsibilities exist in Germany. Their competences are regulated by the German Medicines Act (Arzneimittelgesetz, AMG). The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is responsible for clinical investigations of drugs, medical devices and for performance evaluations of in vitro diagnostic agents, with the exception of those which the Paul-Ehrlich-Institute is responsible for. The Paul-Ehrlich-Institute (PEI) is responsible for performance evaluations of high risk in vitro diagnostic agents like vaccines, sera and blood and plasma derived products.
The Federal Institute for Drugs and Medical Devices is an independent higher federal authority within the portfolio of the Federal Ministry of Health. It is the successor to the Institute for Drugs (Institut für Arzneimittel) founded on 1st July 1975 as part of the now dissolved Federal Health Office (Bundesgesundheitsamt, BGA). One of the main tasks of the BfArM is the authorization of finalized medicinal products on the basis of the German Medicines Act (Arzneimittelgesetz, AMG). In the course of these licensing procedures the authority reviews the proof of efficacy, safety, and adequate pharmaceutical quality of the finalized medicinal products. The authorization of finalized medicinal products includes the approval of requests for authorization of a clinical trial by a sponsor or authorized CRO.
The request for authorization of a clinical trial has to be made in writing. The BfArM's authorization is subsequently assumed, unless it has, within 30 days, stated reasons for denying its consent to a clinical trial. Furthermore, the Federal Institute for Drugs and Medical Devices has to be notified about the end of a trial within 90 days and about interceptions or an interruption within 15 days.
As a full-service CRO, proinnovera supports sponsors in preparing the documents required for the approval of a clinical trial by the competent higher authority in Germany.