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
