Medicines manufacturers can now submit marketing authorisation applications via the MHRA’s International Recognition Procedure (IRP) which went live on 1 January 2024.
The IRP, which enables manufacturers to apply for a medicine’s license in the UK when it has already been approved by one of seven trusted regulators. The process is intended to accelerate UK patient access to novel treatments.
Applications under the IRP can be received through one of two recognised routes. The assessment times for authorisations are set at between 60 to 110 days – shorter than the previous 150-day timeline.
“With this new application procedure [now] fully live, we are delighted to have created a further, innovative route for bringing new medicines to UK patients”, said Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access.
“IRP allows us to access the expertise of trusted regulatory partners, [that] have already authorised products … our partners can consider applications based on MHRA authorisations, creating a ‘win-win’ for regulators, developers of innovative treatments, and patients”.
Regulatory Rapporteur: MHRA publishes ‘recognition route’ revised guidance
Regulatory Rapporteur: MHRA seals deal for fast international recognition routes