CATrialAuthorisation object
Regulatory and ethics bodies involved in approval process
Competent Authority/-ies (CA)
Ethics committee(s)
Agency for data protection
Other
CA - Submission for authorisation mandatory for
All clinical trials on Medicinal Products (MP)
CA - Registration/ notification without approval required for
Non-interventional IMP trials
CA - Submission required to
National CA
National trial registry - Registration mandatory
Yes
National legal framework in place
Yes
Applicable national legal framework/ Reference
All interventional research on medicinal products, regardless of the potential risk level, require authorization by the ANSM. ( Cf. "Jardé law", see also Articles L. 1121-1, 1°, L1123-8, L1123-12, etc of the Public Health Code)
Non-interventional research must be notified to the ANSM but doesn't require authorization. ( Cf. "Jardé law", see also Article L. 1121-1, 3° of the Public Health Code)
