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Editor's Note

Posted on 27 November 2020

Welcome to the Autumn edition of Inside Life Sciences.

As I write, we are in the middle of the second period of an England-wide lockdown and in the inevitable turmoil, with the very serious restrictions and difficulties this imposes on everyone, attention may understandably have shifted way from Brexit.

Yes, before we all became weary from dealing with the consequences of COVID-19 it is fair to say that we were becoming very weary of all things Brexit. Understandable, but as the transition period is due to expire at the end of this year, we must turn our attention to this once more because, as I write, a formal trade deal has still not been agreed between the EU.

The MHRA has been soldiering on and, notwithstanding the huge additional regulatory demands placed on it by COVID-19, has produced an impressive array of guidance documents, some still in consultation form, to set out the framework for how medicines and medical devices will be regulated in the UK following the end of the transition period. Of course, there are further implications of a "no trade deal" exit, but in any event the UK will become a "third country" in respect of the EU. The guidance from the MHRA covers:

  • the regulation of medical devices (see our article in this newsletter);
  • the regime for the licensing of medicines, including how existing EU marketing authorisations will be connected in UK MA's and vice versa;
  • how advanced therapies and biosimilars will be regulated (see my article on the new UK regulation for biosimilars in this newsletter);
  • clinical trials and the oversight of interventional products being trialled in the UK (see the article by Stefania Littleboy and Oliver Millichap in this newsletter);
  • import and export, and the need to hold or obtain a wholesale dealer authorisation; and
  • Pharmacovigilance and the change to the EU PV system, most notably the need for a "national contact person" based in the UK to report to the qualified person if the QP is based in the EU.

I normally resist inserting "lists" of matters in an introduction, but the above gives some indication of the size and complexity of the task to manage the implications of Brexit. The Life Sciences industry is a huge part of the UK economy and there is a huge incentive to smooth out the bumps of the transition, but the continuing uncertainty on a trade deal with the EU is not helping.

Finally, we hosted a webinar recently on the adoption of artificial intelligence and machine learning by the Life Sciences industry and some of the implications of this, which you can watch here.

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