Navigating the process complexities and challenges associated with EU-CTR transition applications

AdobeStock_94576008

Abstract

From 31 January 2025, clinical trials authorised under the old EU Clinical Trial Directive (CTD) must either have ended in the EU/EEA or have been transitioned to new EU Clinical Trial Regulation (CTR). Therefore, any ongoing trial with at least one active site in the EU beyond 30 January 2025 needs to be transitioned to the CTR before expiry of the transition period. The EU Clinical Trial Coordination Group (CTCG) has agreed on an expedited, harmonised member state (MS) evaluation procedure based on the validation of minimum application dossiers restricted to documents already authorised under the EU CTD.

How to read this journal article 

Thank you for visiting Regulatory Rapporteur. Journal articles are restricted to TOPRA members and registered users.

If you are a TOPRA member, or have already registered for limited free access, log in now (Option 1 below).

Not yet a member? You can either join TOPRA (Option 2 below) or register to view limited content for free (Option 3 below).

1. LOGIN

Already a TOPRA member?

Log in now using your MyTOPRA credentials, for unlimited access to all Regulatory Rapporteur journal articles, the online archive and latest industry news and podcasts.

Already registered for free content?

If you are not a TOPRA member but have already created an account to access limited free content, log in here using your registered user email and password.

Login

2. JOIN TOPRA

Special offer on
TOPRA membership

Join TOPRA today and get membership until the end of 2026 for the exclusive rate of £230.

In addition to unlimited access to Regulatory Rapporteur content, as a TOPRA member you will also be able to enjoy a wide range of benefits including career boosting resources, savings on our events and training, and access to our regional networks and special interest groups.

This offer ends 30 September 2025

Become a member

3. REGISTER FOR FREE

Want free access to selected content?

Register now to continue to access industry news, editorials and podcasts plus one member-only journal article each month.

  • Create your own library to save your favourite content.
Create a free account