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
Ministry of Health, Welfare and Sport (VWS)
National trial registry - Registration mandatory
Yes
National trial registry
The Nederlands Trial Register (NTR)
National legal framework in place
Yes
Applicable national legal framework/ Reference
Section 13i(5) WMO (en)
Additional Information
Clinical trials must be submitted to the relevant CA (CCMO or VWS) for a second extra marginal assessment (alongside the EC’s review).
Concerned CA:
• CCMO: acting as CA for research with a MP that is reviewed by an accredited MREC.
• VWS: for research with a MP that is reviewed by the CCMO as reviewing EC
