Mid-June Launch For EMA’s Simplified Online Orphan Designation Filing System
Executive Summary
The European Medicines Agency will encourage companies to submit their orphan designation applications through a new portal when it is launched on June 15. Applications through existing processes will be accepted until Sept. 15.
You may also be interested in...
Faster Submissions For Orphan Designation Possible As EMA’s Online Portal Goes Live
The new portal is expected to provide an improved method for applying for and managing EU orphan drug designations.
Three Sponsors To Test EMA’s New Online Orphan Designation System
The European Medicines Agency is developing a new, simplified online system for receiving and managing orphan drug designation applications. Three prospective sponsors have volunteered to test the new system, which is scheduled to go live in early summer.
EU Consults On What Constitutes Personal & Commercially Confidential Data In Marketing Applications
Based on their experience with dealing with requests for access to documents over the past 12 years, EU regulators have proposed updating their guideline that provides for a harmonized approach to protecting personal data and business secrets in marketing authorization applications.