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.
“Investigational medicinal products used in clinical trials can be imported only after their batch-release has been certified by a qualified person in the EU,” the agencies write, noting that as of 1 July 2020, there were 250 trials registered in EudraCT and authorized in an EU member state within the last three years where the qualified person is based in the UK.
“Sponsor of all ongoing trials need to establish a [qualified person] in the EU. Failure to do so could in the worst case result in discontinuation of the trial treatment and thus jeopardize trial participants’ safety,” the agencies write.
Similarly, the agencies say there are 200 trials registered in EudraCT and authorized in at least one EU member state within the last three years where the sponsor is established in the UK.
Failing to establish a legal presence in the EU, “will be a breach of Directive 2001/20/EC and could trigger a request for corrective actions by Member State competent authorities,” the agencies note.