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

Clinical Trial Regulation: EU Clarifies Requirements For Patient-Facing Documents

Executive Summary

An updated Q&A on the EU Clinical Trial Regulation distinguishes between patient-facing documents and recruitment material to clarify in which sections of the trial application these should be submitted. It also underlines the main principles to consider for transitioning studies from the Clinical Trials Directive to the CTR.

You may also be interested in...



Straightforward But Technical: Transferring Existing Studies To EU Clinical Trial Portal

At a webinar organized by the European Medicines Agency, EU member states discussed their experiences with reviewing the requests made by trial sponsors to switch existing studies to the Clinical Trial Regulation.

Saudi FDA Finalizes Approach To Commercial Info In Public Assessment Reports

Saudi Arabia has explained what information on a drug’s review will be made public following a marketing authorization decision. 

EU Finalizes Option To Omit Expiry Date On Inner Labeling Of Investigational Drugs

Revised labeling requirements for unauthorized investigational and auxiliary medicinal products under the EU Clinical Trial Regulation have been published in the Official Journal.

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS147061

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