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 Loses Key Round In Court Battle For Flagship Transparency Policy

EU Advocate General says clinical trial data are presumptively confidential

Executive Summary

The European Medicines Agency may be forced to re-examine whether clinical trial data should be regarded as presumptively confidential under its access to documents policy.

You may also be interested in...



Big Win For EMA On Transparency

The European Court of Justice has confirmed the European Medicines Agency’s approach to disclosure of data submitted as part of a marketing authorization application. It is a big disappointment for industry, which nonetheless says it supports responsible data sharing and will support efforts to develop a balanced approach.

Transparency Advocates Urge Upholding EMA’s Access To Documents Policy

A number of transparency supporters have issued an open letter ahead of an EU court judgment on the European Medicines Agency’s access to documents policy. 

Industry Pricing Tactics Are Driving Europe’s Cross-Country Backlash

A recent event in Brussels organized by the European Public Health Alliance found that cross-country initiatives on pricing and calls for more R&D and clinical trial transparency are gathering momentum in Europe, but there is still some way to go to address the imbalances in the system. The Pink Sheet spoke to EPHA's Yannis Natsis about the issues raised at the organization's fourth forum on medicines access.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS140964

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