From 1 January 2024, developers of new medicines can now submit
applications via the MHRA’s new, International Recognition
procedure (IRP).
The IRP will help bring life-saving medicines to UK patients and
has been developed by the MHRA following the UK’s departure from
the European Union. It allows the Agency to take into account the
expertise of trusted regulatory partners in other countries when
authorising medicines.
As a sovereign regulator, the MHRA retains ultimate authority to
accept or reject applications submitted under the IRP – but the
shared, global expertise inherent in the IRP process is designed
to result in a more rapid, efficient, and cost-effective process
for applicants.
Beach, MHRA Interim Executive
Director of Healthcare Quality and Access, said:
With this new application procedure fully live, we are delighted
to have created a further, innovative route for bringing new
medicines to UK patients.
IRP allows us to access the expertise of trusted regulatory
partners, who have already authorised products. In return, our
partners can consider applications based on MHRA authorisations,
creating a ‘win-win’ for regulators, developers of innovative
treatments, and patients.
Health Minister, , said:
Today’s announcement shows how organisations can maximise Brexit
freedoms, accelerating patient access to new medicines on the NHS
and putting the UK on the forefront of medical innovation.
We’re making it easier than ever for patients to receive the
life-saving medicines they may need, faster.
This new international recognition procedure will speed up the
licensing process by allowing access to the expertise of other
trusted regulatory partners, including those in Australia, Canada
and Switzerland.
At launch, the MHRA will partner with regulators in Australia,
Canada, Japan, Singapore, Switzerland and the USA, as well as the
European Medicines Agency, individual EU member states and those
in the EEA (European Economic Area).
Applications under IRP can be received via the MHRA website under
one of two recognised routes. Time horizons for authorisations
are set at 60 to 110 days – considerably shorter than the current
150-day time horizon for applications.
To further streamline the IRP application process, the MHRA
launched an ‘Eligibility Checker’ tool on 20 November 2023. Six
weeks prior to making a full submission under IRP, applicants
should use this tool to determine whether their Marketing
Authorisation Application (MAA) is suitable and to identify which
route (A or B) to follow.
