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
Specific Competent Authority for ATMP trials in place
Yes
Competent Authority for ATMP trials
Bundesministerium für Gesundheit BMfG (Federal Ministry of Health)
National trial registry - Registration mandatory
No
National legal framework in place
Yes
![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 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](/media/cms_page_media/2015/11/10/flag_yellow_low_100.jpg)