BRIEF—EC consults on orphan designation processes

The European Commission (EC) is  consulting on the format and content of applications for designation as orphan medicinal products and on the transfer of designations from one sponsor to another.

Comments received will be taken into account by the EC as it finalizes guidance that was initially drawn up last year to address the European Medicines Agency’s new online portal for orphan drug submissions.

The previous guidance pre-dates the launch of the online platform.