Clinical Trials / GCP Inspections
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 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
Phone: +49 - 228 - 207 - 4318
Fax: +49 - 228 - 207 - 4355
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 (file size: 1,019 KB)
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.
New informations in the topic Clinical Trials
Electronic submission of clinical trial applications
BfArM and PEI publish a file structure for electronic data carriers (CD-ROM/DVD) for the submission of clinical trial applications for medicinal products.
Annual Safety Reports as Development Safety Update Reports (DSUR)
Answers to frequently asked questions regarding the new form of annual safety report, the DSUR, have been harmonised on the European level by the Clinical Trial Facilitation Group (CTFG).
GMP issues with the contract manufacturer Ben Venue Laboratories (BVL), Ohio, USA: Effects on clinical trials of medicinal products
Effects on clinical trials with medicinal products containing one of the following active ingredients: anidulafungin, PEG-L-asparaginase, azacitidine, aztreonam, bivalirudin, bortezomib, busulfan, carmustine, cidofovir, eculizumab, histamin hydrochloride, mifamurtide, liposomal doxorubicin, hexaminolaevuniate, oxaliplatin, perflutren, raltitrexed, ribavirin, romidepsin, temsirolimus, telavancin, tetrakis (2-methoxy isobutyl isonitrile) copper (I) tetrafluoroborate
The EudraCT PUBLIC applications for creating the Clinical Trial Application Form (Annex 1 pdf and xml) have been upgraded to v8.1. The upgraded version should allow a more user friendly completion of the form.