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

Despite Brexit, UK Regulator Remains Pharma Favorite – For Now

Executive Summary

The European medicines regulatory network is planning for a worst-case scenario and is advising drug companies to do the same to ensure there are no last-minute disruptions when the UK leaves the EU at the end of March 2019. It appears this advice has yet to have an effect on the industry’s preference for the UK to lead the evaluation of human medicines under the decentralized procedure. The Pink Sheet‘s Vibha Sharma spoke to two senior national regulators to find out how the network is coping with the situation.

You may also be interested in...



Change And More Change: That’s What Brexit Means For Drug Companies

The EU medicines network has issued a long list of changes that drug companies with activities in the UK will have to make if they are to continue to be located from a regulatory standpoint in the European Economic Area following Brexit. Aspects affected include the location of orphan designation holders, qualified persons for pharmacovigilance, companies’ manufacturing and batch release sites and maintenance of SME status.

EU National Agencies Prepare For ‘Rebalancing’ Of Network Post Brexit

The UK has formally notified the EU of its plans to leave the trading bloc and formal Brexit talks will begin soon. In the meantime, pharmaceutical regulators in the remaining 27 EU member states are having to plan for a future without the UK regulatory agency, the MHRA. In the UK, “Day 1” of Brexit is focusing minds.

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.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS121032

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