Europe – EU agencies urge sponsors to ensure post-Brexit compliance with clinical trial rules

In a notice issued on Thursday, the European Commission, European Medicines Agency and Heads of Medicines Agencies reminded clinical trial sponsors that they must comply with EU clinical trial rules following the Brexit transition period that expires on 31 December 2020.
 
With the deadline to extend the transition period now passed, “There is no possibility for further extension beyond that date,” the agencies write, pointing trial sponsors to the Commission’s Brexit readiness notice for clinical trials.
 
Specifically, the notice reminds sponsors that they must have a qualified person established in the EU or European Economic Area and that the sponsor themselves or a legal representative must be established in the EU to ensure smooth operation of their ongoing studies…