On 21-Dec the EU authorities released a festive treat for those of us interested in the EU Clinical Trial Regulation – two new updates to guidance!
– The EU Commission Q&A relating to EU CTR – v6.7
The aim of this document is to provide general guidance on the implementation of the CTR, and should be read in combination with:
– Guidance for the Transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation.
– More specific documents published on Eudralex 10:
Chapter 7 on “Safety Reporting” was drafted by the Clinical Trials Facilitation and Coordination Group of the Heads of Medicines Agency (CTFG) and endorsed by the Expert Group on Clinical Trials of the European Commission.
Q&A 2.8 “How to use conditions” was endorsed also by CTFG.
And second update:
– Guidance on Transition of Trials – 21Dec2023
Overall the updates are relatively minor, with the Q&A including additional clarifications relating to safety reporting and other changes reflecting much of the evolution of guidance occurring in other areas. It is great that the authorities continue to provide regular updates and nice to see continuation in flexibility within the guidance released!
Note: The new EU Clinical Trials Regulation represents the most significant overhaul of clinical trial requirements in Europe for a generation.
The EU Clinical Trials Regulation 536/2014 (EU CTR) was designed with the aim of increasing attractiveness of the EU relative to other regions where performance of clinical trials may be perceived as easier when compared with the many different requirements and timelines applying across different EU countries.