UK MHRA to recognise medicine approvals including from FDA and EMA

The new recognition routes will provide a fast-track UK application process for products already licensed in the trusted partner markets listed above, with the MHRA retaining responsibility for approving such accelerated applications. The new routes will build on the MHRA’s existing European Commission (EC) Decision Reliance Procedure, which enables marketing authorisation applications for Great Britain to be based on the European Commission’s decision to grant an EU centralised marketing authorisation and the applicant to receive an accelerated decision from the MHRA within 67 days or less. It also complements the UK national authorisation process and accelerated access route, the Innovative Licensing and Access Pathway (ILAP).

The introduction of the new international recognition routes is a milestone development in the UK’s medicines regulatory framework and is intended to result in faster access for UK patients to new innovative medicines already been authorised in a trusted partner market.

Next steps

The new routes will need to be implemented through an amendment to the current UK medicines regulation, with draft legislation likely to be published in late 2023 for approval by Parliament before the current EC Decision Reliance Procedure expires out at the end of 2023.

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Authored by Jane Summerfield.