Friday, October 5, 2018
The ECFS Patient Registry, in successful collaboration with national registries, has been qualified by the EMA as an appropriate platform for the collection of CF data for Post Authorisation Safety Studies and Post Authorisation Efficacy studies. These studies support regulatory decision making for medicines used in the treatment of CF.
We are pleased to announce that EMA has confirmed a final opinion. The updated and final Context of Use document is available on the EMA website.