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by Louise Place
Currently, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) is responsible for just under a third of applications and updates for European medicinal product marketing authorisations – but on 29 March 2019 the UK will no longer be part of the European Union (EU).
I was struck by the enormity of the challenges ahead when I attended a recent meeting staged by The Organisation for Professionals in Regulatory Affairs (TOPRA). The title of the meeting was: ‘Preparing for the future: a conversation with the heads of medicines agencies’.
Change is nothing new in medical regulation – over the last year or so we have already familiarised ourselves with changes relating to European device submissions. For example, changes to the Medical Devices and In Vitro Diagnostic Directives (evolving into the Medical Devices Regulation and In Vitro Diagnostic Regulations respectively) as well as the pending Clinical Trials Regulation and update to the Falsified Medicines Directive. We’ve also adapted to changes to the Quality Management System standard for Medical Devices (ISO 13485) and are keeping a close eye on those being discussed for the Risk Management standard (ISO 14971).
However, this will pale into insignificance compared with the changes resulting from the UK’s decision to withdraw from the EU. Currently, on the departure date of 29 March 2019, the UK will become a ‘third country’ and the European Medicines Agency (EMA) is preparing for the worst-case scenario. There are two key aspects:
1. Continuing to market in Europe – companies that wish to continue to supply the EU, and currently hold marketing authorisations from the MHRA in the UK, would need to transition to a new European agency. Additionally, those based in the UK would need to appoint an authorised representative within an EU country, as non-EU-based companies are already required to do. I was surprised to hear that this may affect 6,000 medicinal products – no small task.
2. A new process for the UK – things won’t get easier, either, for those wanting to market in the UK. Currently, little is known about what the requirements for marketing in a post-Brexit UK might be – but there is likely to be some impact. My personal view is that, in the short term at least, the requirements won’t be too different from those in the EU. But what this will look like in the medium to long term, as viewpoints diverge, is currently anyone’s guess.
When, post Brexit, the UK’s MHRA can no longer authorise medicines for the EU market, there will be a significant additional workload for the remaining 27 member states. Add to this the recent announcement of the EMA’s relocation from London to Amsterdam – with the associated challenge of staff retention and recruitment – as well as the prospective implementation of a new process for the UK, and suddenly the 16 months remaining to Brexit don’t seem like very long at all!
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