The MHRA and NICE aligned pathway and an improved advice service
will help get new medicines to patients faster and support
companies to plan with more certainty.
Patients in England are set to receive some new medicines three
to six months earlier under a streamlined approval process being
launched by the Medicines and Healthcare products Regulatory
Agency (MHRA) and National Institute for Health and Care
Excellence (NICE).
This follows commitments in the government's 10 Year Health Plan for
England and Life Sciences Sector
Plan for NICE and the MHRA to work together more closely to
get medicines to patients sooner.
The aligned pathway, which launches on 1 April, will help to
bring NICE's decision-making process forward to run alongside
MHRA's, resulting in decisions on licencing and value being made
at the same time.
Alongside the pathway, NICE and the MHRA are also launching an
improved Integrated Scientific Advice service. This will offer a
single-entry point, meeting and report, and one payment, while
aligning data and scientific expectations where possible.
Integrated Scientific Advice has been designed to help companies
follow the aligned pathway timelines by clarifying regulations
and the evidence required early in the development process. This
will help companies improve their clinical development plans and
reduce unforeseen delays.
The launch of both services was announced at the NICE Conference
in Manchester today (Tuesday, 17 March) by Professor Jonathan
Benger, Chief Executive of NICE, and Lawrence Tallon, Chief
Executive of the MHRA.
This joint work does not end here, with more ongoing projects
between the two organisations all helping to align processes and
achieve efficiencies for medicines and medical devices across the
UK health and care system.
Pharmaceutical companies can join a webinar
at 2-3pm GMT on Wednesday, 25 March to find out more about the
aligned pathway and integrated scientific advice service and how
and when to apply.
Dr , Health Innovation and Safety
Minister, said:
As a practising surgeon, I know how important it is that patients
get access to the latest treatments as quickly as possible.
That's why we're cutting red tape so safe and effective new
medicines can reach NHS patients up to six months sooner and get
patients back to full health earlier.
Not only that, but this will also give companies clearer, quicker
decisions - helping make the UK an even more attractive place to
invest in life sciences and bring innovations to market, boosting
the economy in the process.
Professor Jonathan Benger, Chief Executive of NICE,
said:
The services announced today will help to bring safe, effective
medicines to patients faster by aligning licencing and value
assessment decisions. They will give companies predictable
timelines to support effective planning, tell them what evidence
is required earlier in the process and help to remove unnecessary
delays.
By working more closely with our partners at the MHRA, we can get
medicines into the NHS faster, helping to improve peoples'
health, ease pressure on NHS services and support a strong life
sciences industry in this country.
Lawrence Tallon, Chief Executive of the MHRA,
said:
This development with our partners at NICE is about health and
prosperity. A streamlined regulatory system is better for
patients as it means earlier access to innovative medicines by up
to six months. Our continued collaboration also makes the UK an
even more attractive launch market for the global life sciences
industry so will boost R&D investment and economic growth in
this country.
In October 2025, pharmaceutical companies were invited to
register as early adopters. A total of 27 companies signed up,
and the first treatments are currently going through the aligned
pathway, with the first guidance expected in June 2026.
