Clin­i­cal Tri­als

In Germany, the Paul-Ehrlich-Institut is responsible for examining clinical trials in the field of vaccines and biomedicines.

Legal Basis

The twelfth amendment to the Medicinal Products Act (The Drug Law, ArzneimittelgesetzAMG) of 30 July 2004 was announced in the Federal Law Gazette on 5 August 2004. It came into effect on 6 August 2004. The transitional provisions, in particular relating to applications for clinical trial authorisations submitted to the competent Ethics Committee before 6 August 2004, are contained in section 138 of the Act.

Federal Gazette no. 166 dated 4 September 2006 contains a joint announcement from the Paul-Ehrlich-Institut and the Federal Institute for Drugs and Medical Devices (BfArM): the "Third Announcement on Clinical Trials of Medicinal Products on Humans". The full text of this joint announcement may be found on the BfArM website; it relates to applications to the competent higher federal authority for the authorisation of clinical trials pursuant to section 40 sub-section 1 sentence 2 of the Medicines Act (AMG) and section 7 of the ordinance supplementing section 42 sub-section 3 AMG (GCP-V), to the notification of subsequent changes during the conduct of clinical trials pursuant to section 10 as well as to the notification of the termination of a clinical trial pursuant to section 13 sub-sections 8 and 9 of this ordinance.


Unit Clinical Trials
Phone: +49 6103 77 1810

Updated: 21.11.2019