Aligned pathway will streamline decisions on licensing and value
for medicines, helping patients to benefit from them sooner.
Pharmaceutical companies who make qualifying medicines can now
take advantage of a streamlined approvals pathway for medicines
much earlier than anticipated.
The Medicines and Healthcare products Regulatory Agency (MHRA)
and National Institute for Health and Care Excellence (NICE) are
now offering some pharmaceutical companies early access to the
aligned pathway six months earlier than projected, as user
research begins to shape the next phase of the programme. The
pathway is now accepting applications from manufacturers who make
medicines which have been designated by the NICE and the MHRA for
early access.
The aligned pathway delivers on government ambitions in the
Regulatory Action Plan, 10-Year Health Plan for England and the
Life Sciences Sector Plan by streamlining regulation,
accelerating access to medicines for patients and the NHS, and
improving the UK's global competitiveness in life sciences.
The pathway brings together the MHRA's licensing process and
NICE's value assessment process, meaning decisions will be
published at the same time, instead of consecutively. This will
reduce the 90-day gap between marketing authorisation and NICE
guidance decisions, meaning faster patient access, support for
the NHS and a more efficient route for industry.
A new fully integrated joint scientific advice service, launching
by April 2026, will provide a single-entry point for coordinated
advice from the MHRA and NICE to help avoid delays and support
alignment. The service is designed to help companies successfully
adhere to aligned pathway timelines, providing enhanced clarity
and confidence in investment decisions by providing evidence
requirements early and avoiding unnecessary delays.
Pharmaceutical companies are encouraged to register products on
UK PharmaScan at least three
years before marketing authorisation and to engage early with
both organisations.
NICE and the MHRA will continue to work more closely to improve
efficiency, transparency and timely access to innovative
treatments.
Any companies with a technology appraisal already scheduled who
believe their product may be suitable for the aligned pathway
should contact the NICE scheduling team – scheduling@nice.org.uk.
Notes to Editors
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Our joint blog post with further guidance on the aligned
pathway is available here.
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The aligned pathway was announced by the Medicines and
Healthcare products Regulatory Agency (MHRA) and the National
Institute for Health and Care Excellence (NICE) in July
following the publication of the Regulatory Action
Plan from HMT in March 2025.
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Pharmaceutical companies will also need to commit (at global
level) to the Aligned Pathway timelines. To support this
approach, NICE will offer priority scheduling for medicinal
topics following the Aligned Pathway, ensuring these
medicines can progress through its evaluation process in time
to achieve simultaneous publication with regulatory
decisions.
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The National Institute for Health and Care Excellence (NICE)
provides useful and usable guidance for health and care
practitioners, including rigorous, independent assessment of
complex evidence for new health technologies.
