21 July 2023
MHRA Corporate Plan signals international recognition route
The MHRA has published its 2023-2026 Corporate Plan, setting out its core strategic priorities and activities over the coming years.
Regulatory activity is a key component of the plan. Some of the main targets identified by the MHRA are:
By 31 March 2025 – Improve patient access by formalising new recognition pathways for UK approval to “complement our national routes to market and that provide a legal base to allow for expedited access for some medicines and medical devices where these have already been approved by trusted regulators.”
By 31 March 2026 – Deliver UK innovation focussed legislation to strengthen the MHRA’s “ability to support innovation and to simplify the UK healthcare products regulatory regime via established recognition mechanisms.”
These commitments appear to build on the Chancellor’s Spring Budget commitment to an abridged approval route for devices with existing certification from selected international regulators.
The Corporate Plan does not provide detail on how the international recognition model could operate, but does note the MHRA’s ability to forge “bilateral partnerships of mutual interest” referencing the US, Australia, Brazil, Canada, Singapore and Switzerland.