Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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.

UK Warns Against Printing Out EHRs For Clinical Trial Monitors

New UK guidance explains how clinical trial sponsors and investigator sites can ensure that trial monitors securely process data in electronic health record systems that do not have a restricted access functionality.

Topics

UsernamePublicRestriction

Register

LL1121650

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel