Mid-June Launch For EMA’s Simplified Online Orphan Designation Filing System
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.
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The new portal is expected to provide an improved method for applying for and managing EU orphan drug designations.
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.
The UK Medicines and Healthcare products Regulatory Agency is developing a series of guidance documents on general points to consider when planning a trial to generate real-world evidence. The first document in this series focuses on prospective randomized trials.