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Yet More Delay For EU Clinical Trial Regulation

Original Deadline Of October 2018 Has Slipped To Early 2022

 
• By Ian Schofield

Revisions and restructuring of the contract with the developers mean that Europe’s new clinical trials system will not go live next year as planned, although the European Medicines Agency says progress has been made with development of the system. 

Clinical trial
The EU's new clinical trial regulation has hit another delay • Source: Shutterstock

The implementation of the EU Clinical Trial Regulation (CTR) will be delayed again after it was announced that the audit of the planned Clinical Trials Information System will not now begin until the end of 2020. This suggests that the system will not be in use until more than three years after the original deadline.

If the original delivery timescales for the various stages of the audit and application process are adhered to, the delay means the provisions of Regulation No 536/2014 might not take...

More from Europe

EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
• By Eliza Slawther

The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

UK And US Regulators In Sync On RWD External Control Arms

 
• By Vibha Sharma

The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.

New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.

EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

More from Geography

EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
• By Eliza Slawther

The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

UK And US Regulators In Sync On RWD External Control Arms

 
• By Vibha Sharma

The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.

New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.