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


Sponsors Urged To ‘Push Back’ On EU Country-Specific Clinical Trial Requirements

Executive Summary

It has been over five months since the EU Clinical Trial Regulation introduced harmonized requirements for approving new studies. A top European Commission official says that trial sponsors need to keep driving this message home to member states, who are clinging on to their national requirements out of habit.

You may also be interested in...

Updated EU Guide Helps Sponsors Steer Through National Clinical Trial Requirements

The EU guideline on the Clinical Trials Regulation has been updated with a list of member state websites where sponsors can find information on national requirements for trial applications. 

CTIS: EU Member States Seek Advance ‘Warning’ On Lead Assessor Requests

Sponsors keen on a specific EU member state to lead the assessment of their proposed multinational clinical trial are being urged to keep the concerned national competent authority in the loop before submitting the dossier to the Clinical Trial Information System.

EU Clinical Trial Sponsors Reassured On Member State Dossier Requirements

The European Commission wants to ensure that the content of dossiers filed under the EU Clinical Trial Regulation is harmonized to simplify the trial approval process. Any national requirements imposed by member states should have a clear legal basis. 

Related Content


Latest Headlines
See All



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