GNMA 7: Impact of Brexit on the regulatory approval process for medicines in the UK

The end of the transition period marks the end of the Medicines and Healthcare products Regulatory Agency (MHRA)’s participation in the European Medicines Agency (EMA)’s centralised procedure. All companies will now have to apply to the MHRA separately for regulatory approval for new drugs in the UK, although the MHRA will also recognise EU approvals through new decision reliance procedures. The risk associated with this is that many companies may focus their efforts on gaining regulatory approval from the EMA first. In order to mitigate this, and to ensure the UK remains an attractive first launch country in the aftermath of Brexit, the MHRA has introduced new regulatory pathways and joined collaborative international initiatives with the aim of accelerating UK patient access to innovative treatments. In this guidance note we will examine some of these initiatives and their potential impacts and assess whether they might be sufficient to ensure the UK remains a fostering environment after Brexit.

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