CATrialAuthorisation object

Regulatory and ethics bodies involved in approval process

Competent Authority/-ies (CA)
Ethics committee(s)
Agency for data protection

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


National legal framework in place


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)