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

Mandatory Use Of ‘Dysfunctional’ EU Clinical Trial Portal Raises Concern In Germany

EMA Working To Resolve All Remaining Technical Issues As Soon As Possible: Commission

Executive Summary

Efforts are on to address the “serious deficiencies” raised by the German associations for medical ethics committees, trial sponsors, contract research organizations and other stakeholders regarding the EU Clinical Trial Information System that will become mandatory from 31 January 2023.

You may also be interested in...



EMA Offers Weekly Updates On Getting Clinical Trial Portal Ready For Mandatory Use

The European Medicines Agency’s management board is keeping a close tab on ongoing efforts to ensure that the Clinical Trial Information System is stable enough to support its mandatory use by study sponsors from 31 January 2023.

EMA To Address Problems With CTIS By Key January Deadline

The EU’s single-portal Clinical Trial Information System will become mandatory from 31 January 2023 for sponsors seeking clinical trial approval. Problems that some users have experienced while using the system voluntarily are being fixed, according to the European Medicines Agency.

EU Rejects Calls To Extend Clinical Trial Regulation Transition Period

A senior European Commission official has a clear answer for those expecting the mandatory phase of the EU Clinical Trial Regulation to be delayed. There is no such plan on the cards.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS147430

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