Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

EMA PRIME Rejects Told: ‘Add Something New’ If You Resubmit

Executive Summary

The European Medicines Agency says it has been disappointing to see previously rejected applications for its PRIME scheme sent back to the agency with no additional data. On the other hand, the scheme, which is designed to get drugs for unmet medical needs to patients faster, is going from strength to strength. Kick-off meetings are identifying issues that sometime surprise companies but can be dealt with early on, well before a product is filed for authorization.

You may also be interested in...



EMA And National Agency Heads Join Forces On Medicines Availability and Big Data

The European Medicines Agency and the EU Heads of Medicines Agencies network are working together on a broad range of subjects, from big data to the availability of medicines… and of course, Brexit.

Greater Civil Society Involvement in Drug Evaluation Will Bring Challenges, Warns EMA Deputy Head

The European Medicines Agency is keen to highlight its landmark policy on proactive publication of clinical data but it’s aware of the challenges involved in this and other transparency initiatives.

Gene Therapy For Lethal Glycogen Storage Disease Wins EMA PRIME Designation

Investigational products from Ultragenyx and MinervaX secured a place on the European Medicines Agency’s priority medicines scheme this month.

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS119621

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