New regulatory recognition routes for medicines will be
established using approvals from Australia, Canada, the European
Union, Japan, Switzerland, Singapore and the United States, the
Medicines and Healthcare products Regulatory Agency has announced
today.
This means that patients will have access to safe and effective
medicines that have been approved by trusted regulatory partners
in other countries. The new international recognition routes will
sit alongside the MHRA’s own unique innovation pathway for
medicines which integrates early regulatory advice with health
technology assessment advice.
These recognition routes, which have been facilitated by existing
international partnerships such as those developed through
the Access
Consortium and Project Orbis, mark the
start of a new international recognition framework for medicines
that will be in place by the first quarter of 2024.
The new framework will allow the MHRA to make the most of
the expertise and decision-making of trusted regulatory partners
to streamline assessments of specific products. As a result,
cutting-edge medicines that have been approved in other countries
will get to UK patients more quickly, with cost reductions and
streamlined regulatory processes for industry.
As a sovereign regulator, the UK regulator will still be
responsible for approving all ‘recognition route’ applications
under the new framework, ensuring that all products are safe and
of sufficient quality to be licensed in the UK. The MHRA will
maintain rigorous scrutiny and retain the
authority to reject applications if the evidence
provided is considered insufficiently robust.
At the time of the UK’s exit from the European Union, the MHRA
introduced temporary routes to market for European approved
products in Great Britain, known as EU ‘reliance’ routes, to
ensure that patients could continue to have timely access to new
treatments. These temporary routes are due to expire at the end
of 2023.
While the international recognition routes announced today focus
on medicines, work is underway to establish similar routes for
medical devices. As part of this ongoing work, the MHRA will
launch a new targeted consultation on medical devices that will
gather views on a wide range of topics, including recognising
conformity assessments or approvals from international regulatory
partners.
Dr June Raine, MHRA Chief Executive, said:
We are focused on providing UK patients faster access to the
absolute best, most cutting-edge, and safest medical treatments.
By fast-tracking access to approved products from other
countries, we’re ensuring that innovative healthcare solutions
reach those in need without delay.
The introduction of the new routes will complement the work being
done through the MHRA’s Innovative Licensing and
Access Pathway (ILAP), establishing an additional avenue for
accelerated access to life-saving new medicines. Combining MHRA’s
globally recognised high standards with improved flexibility and
a sustained collaborative approach across the healthcare system,
the ILAP is helping reduce the time to market for innovative
treatments by developing medicines that are both regulatory and
access ready.
Through this new dual approach, we will contribute to the
UK’s ambition to be a global science superpower, by making the UK
one of the best places in the world to bring life-changing
healthcare products to patients safely.
A £10m funding from HM Treasury was announced earlier this
year to support the development of this new recognition
framework.
