If you are working with hospitals based in Europe or you are team member of a clinical trials team in a European hospital you are probably already aware of the big change coming into force in 2016.
As part of the effort of EU to make Europe more attractive for research there are some major regulatory changes coming at the end of 2016 as per current planned date.
What is changing?
All regulatory submissions will be performed via a web portal. The sponsors will be able to nominate EU member country, which participate in the clinical trial to be the leading country and coordinate the study review. The nominated country will liaise with all EU countries, which will participate in the clinical trial and provide final assessment of the study.
2) Review process
The web portal (CTA) will be used not just to obtain country level approval but also Ethics Committee approvals. The review process is divided into 2 parts: Part 1 (science) and Part 2 (national information). The sponsor is allowed to submit Part 1 only and submit Part 2 within 2 years.
A member state country can opt-out of the process but then the country will not be able to participate in the clinical trial.
3) Timelines and approval
There are strict timelines and the approval will take 60 up to 91 days upon validation of the application. The extended timeline is applicable in case there are any questions. If the nominated country fails to meet the timeline there will be automatic tacit approval.
The approval will expire within 2 years if a member state has not recruited patients for the study.
4) Substation modification
The term substantial amendment will be replaced by Substantial modification. The approval for substantial modification will be 49 days up to 80 days.
5) Other portal applications
CTA portal will be used for notification for start and end of trial recruitment and serious breaches of GCP.
Author: Olga Peycheva
Olga is a clinical research professional who has been working in clinical research since 2005. She has extensive experience in clinical research in Eastern and Western Europe.
Originally published on 7 Mar 2016