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 Explains Procedure For Parallel Review Of Drugs For EU And Non-EU Markets

Executive Summary

Companies can get the European Medicines Agency’s scientific opinion for their products’ use in EU and non-EU countries at about the same time.

You may also be interested in...



Takeda Test Drives EMA’s Parallel Review Route For EU And Non-EU Markets

A new evaluation route that the European Medicines Agency launched last year came at the right time for Takeda’s dengue vaccine candidate. 

EMA Offers Simultaneous Review Of Products For EU And Non-EU Markets

Companies can have their EU centralized marketing authorization application and submission for an Article 58 opinion (on medicines for use in non-EU countries) reviewed in parallel by the European Medicines Agency. The simultaneous assessment can be helpful when drugs and vaccines are needed for both EU and non-EU populations.

First Drug Approved Under New Scheme To Speed Access In Poorer Countries

Switzerland’s medicines agency has cleared Ferring’s carbetocin for preventing uterine haemorrhage under the Marketing Authorization for Global Health Products (MAGHP) procedure, which is intended to accelerate the approval of new products in low- and middle-income countries. 

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS144208

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