The tool will facilitate a smooth and efficient application for new medicines via the International Recognition procedure (IRP)
The Medicines and Healthcare products Regulatory Agency (MHRA) has introduced a new tool to check the eligibility for marketing authorisation applicants.
Applicants are now required to use the online ‘Eligibility Checker’ tool to determine whether their Marketing Authorisation Application (MAA) is suitable for the Agency’s International Recognition procedure (IRP), which will become operational on 1 January 2024.
The tool will also help applicants identify which route (A or B) to follow, before submitting their IRP application.
Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access, said that the tool has been tailored to “facilitate a smooth and efficient process for marketing authorisation applicants.”
“From today (Monday 20 November), we encourage applicants to begin to use the tool in readiness for making submissions via the International Recognition Procedure from 1 January 2024.
“Once IRP is fully up and running in January, we will have created a further route for bringing new medicines to UK patients,” she added.
The MHRA’s forthcoming International Recognition procedure (IRP) is expected to further help bring life-saving new medicines to UK patients following the UK’s departure from the European Union.
It will allow the Agency to take into account the expertise of trusted regulatory partners in other countries when authorising medicines.
However, the MHRA remains a sovereign regulator and retains ultimate authority to accept or reject such medicines, when determining applications submitted via IRP.
The Agency received £10m from HM Treasury earlier this year to support the development of this new international recognition framework.