National or multinational: general information

The CTR is applicable to national and multinational clinical trials.

National clinical trials will be assessed by the Member State (MS) where the trial is intended to be carried out. For multinational clinical trials there will be a coordinated and consolidated assessment  by the Member States where the trial is intended to be carried out. 

There is the option for a multinational trial to start the application as a national clinical trial and to add one or more member states at a later stage via the procedure Addition of MS (CTR, article 14). Addition of MS can start only after the trial has been authorized in at least one Member State.