CATrialAuthorisation object

Regulatory and ethics bodies involved in approval process

Competent Authority/-ies (CA)
Ethics committee(s)

CA - Submission for authorisation mandatory for

Clinical IMP trials
Clinical ATMP trials

CA - Submission required to

National CA
Regional CA

Specific Competent Authority for ATMP trials in place

Yes

Competent Authority for ATMP trials

Federal Institute for Vaccines and Biomedicine:

National trial registry

National public trial register in Germany: Deutsches Register Klinischer Studien DRKS

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
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