Tasks of the Clincical Trials / GCP Inspection Unit
- Approval of clinical trial applications as competent authority according to Sections 40-42a of the German Medicines Act (AMG) and the GCP Ordinance ( GCP -V)
- Pharmacovigilance in clinical trials (Section 42a AMG, Sections 13 and 14 GCP-V)
- GCP inspections according to Sections 9 and 15 GCP-V (GCP ordinance), Section 25 AMG (German Medicines Act)
Contact
Contact point of the Federal Institute for Drugs and Medical Devices (BfArM) for clinical trial subjects according to Section 40 sub-section 5 AMG:
Bundesinstitut für Arzneimittel und Medizinprodukte
Fachgebiet Klinische Pruefung / Inspektionen
Kurt-Georg-Kiesinger-Allee 3
D-53175 Bonn
GERMANY
Phone: +49 - 228 - 207 - 4318
Fax: +49 - 228 - 207 - 4355
E-Mail: klinpruefung@bfarm.de
In order to provide best possible service we have fixed specific calling times within which you can reach our staff by phone:
Monday - Thursday: 9:00 - 11:00 a.m. (local time)
Friday: 9:30 - 11:30 a.m. (local time)
Whenever possible, please contact our colleagues during these hours.
When contacting the BfArM via e-mail please add "Clinical Trials/GCP Inspections" to the subject line.
Submission of Clinical Trial Applications for Clinical Trials with Medicinal Products
The BfArM provides a guidance document on the submission of clinical trial applications: 
3rd Announcement on Clinical Trials of Medicinal Products in Humans (Größe: 1.04
MB)
Competent Authorities in Germany
According to Section 77 sub-section 2 AMG the Paul Ehrlich Institute (PEI) in Langen is the competent authority for sera, vaccines, blood preparations, bone marrow products, tissue preparations, test allergens, test sera, test antigens, gene transfer medicinal products, somatic cell therapy medicinal products, xenogenic cell therapy medicinal products and genetically engineered blood components. The Federal Institute for Drugs and Medical Devices (BfArM) is the competent authority for all other medicinal products. 
