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

EU Clinical Trial Sponsors Reassured On Member State Dossier Requirements

Executive Summary

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. 

You may also be interested in...



Centralized Templates To Help Harmonize Trial Dossiers Requirements Across The EU

Following feedback from its clinical trials expert group, the European Commission has published new and updated templates that sponsors can use to prepare study applications that would be acceptable in all the EU member states.

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

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.

How The EU Is Keeping Up With Innovation In Clinical Trials

A senior EMA official says Europe has set the ball rolling on presenting a unified approach on clinical trial processes and strategic matters, and is taking steps to ensure there are no roadblocks.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS146022

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