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| 1 minute read

MHRA issues guidance on new International Recognition Procedure (IRP) for streamlining medicine approvals in the UK

The new framework was first floated back in January 2023, as a way for the MHRA to streamline the authorisation process by taking advantage of assessments already conducted by “trusted” regulators in other jurisdictions. In May 2023 the MHRA announced the new international partners as Australia, Canada, Japan, Switzerland, Singapore, the US and the EU – building on existing collaborations through programmes such as Project Orbis (something we also predicted earlier in the year). The IRP is due to replace the EC Decision Reliance Procedure from 1 January 2024 (and it is worth noting that the MHRA is currently running a public consultation on ending the existing Reliance Procedure, which is due to close on 27 September 2023).

This recent guidance sheds more light on how the new IRP will work in practice. It establishes two recognition timetables for initial MA applications:

  • A 60-day timetable under “Recognition A” which applies to approvals from other regulators granted within the previous 2 years and provided the manufacturing process is the same as that already approved by the other regulator.
  • A 110-day timetable under “Recognition B” which applies to approvals granted within the previous 10 years and will be triggered if any one of a range of criteria are met.

In each case the MHRA will conduct a “targeted assessment” of each application, but will “retain the authority to reject applications if the evidence provided is considered insufficiently robust”. The new procedure will undoubtedly offer speedier routes to market for new medicines, with the MHRA positioning the UK as an attractive prospect for new medicine manufacturers.

It will also be interesting to see how these new expedited authorisation pathways impact on pan-EU litigation strategies, particularly given the UPC is now up-and-running. For example, earlier UK-specific marketing authorisations could see the UK courts featuring as the first forum for infringement or clearing the way disputes ahead of the UPC.

Following announcement in May of the new scheme to replace the current EC Decision Reliance Procedure (ECDRP) on 1 January 2024, this guidance informs the sector on how they can use the scheme to apply for a medicine licence in the UK, following approval by trusted regulatory partners in Australia, Canada, the European Union, Japan, Switzerland, Singapore, and the United States. This means that patients will have faster access to safe, effective cutting-edge medicines through our review and by leveraging the expert decision-making of our regulatory partners to streamline assessments of specific products, while maintaining the power of the MHRA as a sovereign regulator to scrutinise each application and the authority to reject them if the evidence provided is considered insufficiently robust.


life sciences, litigation & disputes, patents, pharmaceuticals, upc, biotech, yes, lsstrategysummit