In Germany, the Paul-Ehrlich-Institut is responsible for examining clinical trials in the field of vaccines and biomedicines.
The twelfth amendment to the Medicinal Products Act (The Drug Law, Arzneimittelgesetz – AMG) 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.
New Rules for Governance of Clinical Trials
Regulation (EU) No. 536/2014 on clinical trials on medicinal products for human use will become applicable on 31 January 2022. The Federal Ministry of Health (BMG) and the higher federal authorities BfArM and the Paul-Ehrlich-Institut have prepared information on the new regulation to support harmonised application and interpretation by the German federal states when the new rules for governance of clinical trials come into force.
Information from the BMG, BfArM and PEI: Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use - Date of application, transitional periods and new definitions (German only)
EMA Presentation: Clinical Trials Information System (CTIS)
Unit Clinical Trials
Phone: +49 6103 77 1810