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


Centralized Templates To Help Harmonize Trial Dossiers Requirements Across The EU

New Template Issued To State Compliance With EU Data Protection Legislation

Executive Summary

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.

You may also be interested in...

Commission To Examine Uptake Of EU CTR Templates For Limiting National Divergences

The European Commission says it is keen support harmonization of national requirements under the EU Clinical Trials Regulation and wants to explore how the so-called part II templates have helped on this front and whether new ones are needed.

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. 

Not A Smooth Ride: How One Of The First Studies Navigated The EU Clinical Trial Portal

From grappling with a never-ending list of conflicting national requirements to dealing with numerous technical issues, a research project manager at Norway’s Oslo University Hospital talks about the hiccups faced by their multinational COVID-19 platform trial that was among the first studies submitted for approval under the EU Clinical Trial Regulation.

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