Brexit, Regulatory Update

ACUTA RIM Shots – August 16 Special Brexit Edition

Lots of Brexit-oriented news in recent days that affects the biotech industry.

UK/EMA Separation Implementation Period

First of all, in March, the EU and UK agreed to an ‘implementation period’ for medicines to give a little more time for the European Medicines Agency (EMA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) to  untangle their drug registrations, where products were approved in the UK but used elsewhere in Europe, or vice versa. A guide has been published recently that explains the impact of that period, which runs through December 2020. Essentially, any EU regulation that starts ahead of December 2020 must still be implemented. This includes the EU Clinical Trials Regulation, Falsified Medicines Directive, and Medical Devices Regulation (but not the In-Vitro Devices portion). In the mean time, MHRA are working to ensure that centralised, mutual recognition or decentralized procedures that had the primary review at MHRA will be transferred to another authority  — and in fact they completed the identification of where drug reviews will be transferred in April of 2018. Note that between the time of the Brexit separation and the end of the implementation period, however, UK will not have voting rights within the EMA.  This lets off a bit of the pressure, but MHRA still has a lot of work to do.

Transfers between UK and other Affiliates

RAPS Regulatory Focus reports that EMA has updated guidance on XEVMPD (Extended Eudravigilance Medicinal Product Dictionary) submissions to permit transfer of product authorisations between various affiliates. Typically, transfers of authorisations happen when a product is acquired by another company; this permits products to be moved to a different affiliate location within the same company, moving the Qualified Person for Pharmacovigilance (QPPV) and Sponsor or Market Authorisation Holder (MAH) to a new location. This obviously has a significant impact on Brexit, as products authorised in the EU must have a Sponsor or MAH and the safety process handled within the EU area. As Regulatory Focus points out, this is only one piece of the puzzle of transferring the authorisation, but at least the XEVMPD instructions are now clear.

EMA Staffing Impact

Biotech news site labiotech.eu reports that EMA expects to lose 30% of their staff in the run-up to Brexit and transfer of headquarters to Amsterdam, significantly more than they had anticipated. Because of this, certain international activities will be scaled back starting, leaving EMA in more of a “reactive” status until the transfer — and new hiring — is completed. Regulations and guidelines will only be created for urgent needs, no new activities will be started, and most significantly, clinical data submitted after August 1, 2018 will not be published, although all studies prior to August 1 will be published by October 1. EMA has published a Business Continuity plan for the Human and Veterinary Medicines divisions, describing what else will be affected.

Image credit: j.sutt

Author: Joel Finkle

Joel became embroiled in electronic submissions when regulatory came downstairs and asked "Can we convert all our clinical study reports to WordPerfect format for the FDA reviewer?" and he didn't say, "No." Since then, he's been involved with custom CANDAs, PDF publishing, eCTD, document template automation, Regulatory Information Management, HL7's RPS, and the ISO IDMP standard. He joined ACUTA in April of 2017. He'd share some of his famous tomatillo salsa with you, but he can't carry it on airplanes.

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