LSHC Horizons Brochure 2024 - Flipbook - Page 85
Hogan Lovells | 2024 Life Sciences and Health Care Horizons | Europe
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UK: Delivering on regulatory flexibility
The UK Government committed in its
Life Science Vision to deliver a progressive
regulatory environment in the UK post-Brexit
to support innovation and accelerated access
to new medicines and medical technologies.
In line with this, the UK regulatory environment
for medicines and medical devices is undergoing
significant changes, providing new opportunities
such as enabling companies to apply for UK
authorization based on a product authorization
from another trusted market, allowing medical
devices companies with additional time to
transition to the future requirements, and
providing more detailed guidance to support
compliance of AI and software medical devices.
The regulatory measures introduced in the
UK include:
• the International Recognition Procedure
(IRP): From 1 January 2024, an expedited
pathway to obtain a marketing authorization
is available for medicines that have already
been approved by a “Recognised Regulator”
in Australia, Canada, the European Union,
Japan, Singapore, Switzerland or the United
States. Approvals will be granted in accordance
with a 60-day or 110-day timetable, depending
on the product type and the time since its
approval by the relevant Recognised Regulator.
The IRP can be used for innovator, generic
and biosimilar applications as well as line
extensions and variations;
Jane Summerfield
Partner
London
• a shorter standard marketing authorization
process which has a 150-day application
timetable rather than 210-day;
• a rolling review (RR) process for marketing
authorizations involving a phased approach
where the applicant can submit modules of
the electronic Common Technical Document
(eCTD) dossier in separate parts for preassessment rather than waiting to make a
full consolidated submission;
• the Innovative Licensing and Access
Pathway (ILAP): Under ILAP, medicines
in pre-clinical or clinical development that
qualify for an “Innovation Passport” benefit
from an accelerated pathway to market.
The UK medicine regulator, the Medicines
and Healthcare products Regulatory
Agency (MHRA), and partners including
the National Institute for Health and
Care Excellence (NICE), create a “Target
Development Profile” that sets out a productspecific licensing and access plan;
• participation in Project Orbis which is a
program co-ordinated by FDA to improve
the efficiency of regulatory submissions
and assessment of promising new oncology
products;
• as well as procedural changes to better align
the submission of clinical trial authorization
with ethics committee approvals and
marketing authorizations with the health
technology assessment (HTA) process.
Alexandra Wood
Associate
London
There are also significant changes in relation
to the regulation of medical devices, with the
Innovative Devices Access Pathway (IDAP)
offering a supported research and access route
for innovative medical devices through the
creation of a Target Development Profile (TDP)
and a roadmap for reforming UK medical
device legislation to more closely align with
current EU medical device legislation, but with
greater flexibility and more detailed guidance
for software and artificial intelligence as a
medical device.
A key question over the coming years will be
how the UK responds to regulatory changes in
other markets, in particular to the proposed
revision of data and market regulatory
exclusivity periods in the EU’s pharmaceutical
legislation. UK regulatory exclusivities
currently remain aligned with the existing EU
position and any decision to change or not to
change these in the UK will need to balance
the stated aims of supporting innovation and
accelerating access for patients.
