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

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.

MAP BioPharma has published a guidance note with N-Site to 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.

Initiatives outlined in the guidance note include:

  •  The Innovative Licensing and Access Pathway (ILAP), the first step of which is the Innovation Passport designation, followed by a Target Development Profile

  •  Two international initiatives: Project Orbis and Access Consortium

  •  Conditional and exceptional marketing authorisations

  •  Three decision reliance procedures: the European Commission (EC) Decision Reliance Procedure, the Decentralised and Mutual Recognition Reliance Procedure (MRDCRP) and the Unfettered Access Procedure (UAP).

The guidance note provides an overview of these initiatives and an analysis of how the post-Brexit landscape could impact access to innovative medicines for patients in the UK. To view the full guidance note, visit the N-Site website and create a subscription account to view resources free of charge.

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