CLINICAL TRIALS

With the end of the Brexit transition period on 31 December 2020, the known conditions will change and pharmaceutical companies not prepared will face serious issues and uncertainties. No extension of the transition period has been requested, and according to a joint technical notice by the European Commission, EMA and HMA, no further prolongation beyond 2020 is possible. EU pharmaceutical law will no longer apply for the UK.

Amina Covic, Head Proposal & Competence Management I Qualified Person, ABF Pharmaceutical Services I Member of GBA Group Pharma

Early this summer the EU Commission and regulatory authorities warned in a technical notice that healthcare companies could meet significant business difficulties when running EU clinical trials through UK-based Qualified Persons (QPs).

As of 1 January 2021, UK-based QPs will no longer be able to certify clinical trial batches for the EU. Pharmaceutical companies are at this time in the last months to establish the required changes to comply with the EU pharmaceutical law. Consequences, such as high economic costs or even trial failure will be unavoidable for unprepared pharmaceutical companies.

The EU notice

The technical notice issued by the European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) stated, "lnvestigational medicinal products used in clinical trials can be imported only after their batch-release has been certified by a qualified person in the EU". Highlighting, "Failure to do so could in the worst-case result in discontinuation of trial and jeopardise trial participants' safety." 1

The note also stated that as of July, within the last 3 years there were 250 trials registered in the European Clinical Trials database (EudraCT), with UKestablished QPs. These trials are authorised in at least one Member State other than the UK.2

Clear message is "sponsors of all ongoing trials need to establish a QP in the EU". Further according to Article 19 of Directive 2001/20/EC, "the sponsor of a clinical trial or a legal representative must be established in the EU".

The Solution

GBA Group Pharma is established in EU with GMP manufacturing and testing sites including a central laboratory and offers a one-stop-shop solution for pharmaceutical companies to deal with BR EXIT issues. So, how to deal now with the clinical trials in EU from 1 January 2021? The GBA Group Pharma brings solutions for the sponsors and represents the key partner for clinical trial services in compliance with EU pharmaceutical law. The GBA EU QP Team is responsible for the QP certifications. Further IMP services as import, testing, storage & distribution or labelling and packaging services are part of the one-stop-shop solution. Furthermore, in services for authorised medicinal products GBA Group Pharma will be a key partner.

1 Technical notice to sponsors regarding continuous compliance with the EU legislation for clinical trials1 following the withdrawal of the United Kingdom from the EU, Joint technical notice by the European Commission, EMA and HMA from July 2020

2 As of 1 July, 2020, based on data registered in the European Clinical Trials database (EudraCT)

You can find our article on page 58 of the last special issue of the European Biotechnology Magazine: https://lnkd.in/ggs39FY