In Germany, clinical trials need to be approved by the Regulatory Authority and, depending on the location of the trial sites, the involved Ethics Committees.
There are two regulatory authorities in Germany, depending on the type of study drug either the „Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) or the „Paul-Ehrlich-Institute (PEI)“ is responsible for the assessment and approval of the clinical trial. The regulatory authorities in Germany focus on the preclinical, clinical and quality data of the study drug as well as on the study protocol during their assessment.
The review process of the involved local ECs (LEC) is coordinated through a so-called „Central EC“ (CEC), this is usually the EC that is assigned to the site of the coordinating PI for Germany (Leiter der klinischen Prüfung). The advantage for applicants is that all correspondence (from application to approval) is routed through the CEC, which simplifies the process greatly. The ECs focus their review on ethical aspects of the study, the study protocol, the suitability of patient facing documents as well as on the qualification of sites and study staff.
Finally, the supervision of clinical trials is the responsibility of the local federal competent authorities (Regierungspräsidien) - each federal state in Germany has at least one local competent authority. The local competent authorities need to be informed about each clinical trial prior to study start. Changes at sites or amendments to the study documentation need to be notified to these local bodies as well.
We work independently with national assignments or as a part of a multinational team within LINK Medical
From our office in Berlin, we work independently with national assignments or as a part of a multinational team within the LINK Medical organization. We also benefit from the colla-boration with the various functional groups and resources within LINK Medical’s organization
in Norway and Sweden.
Find more information about how we work under more about clinical trials or contact us directly.