Plans are advancing for a new regulatory pathway that facilitates
the development of innovative technologies, by providing
innovators and manufacturers with a multi-partner support service
including targeted scientific advice that brings new products to
patients sooner.
Set for launch later in 2023, the IDAP will be run by the
MHRA, NICE, and other
partners, including the devolved administrations.
The ambition of this new programme is to bring innovative
technologies and solutions to the forefront of the National
Health Service (NHS), through a new, integrated support service
for developers that will include enhanced opportunities for
engagement.
The aim is to help take uncertainty out of the route to access,
bringing innovative technologies to patients that can transform
health outcomes.
From today, innovators of medical technology (commercial or
non-commercial, UK based or international) that addresses
clinical needs are being encouraged to register for further
information ahead of a planned 2023 pilot launch. Please send an
email with details to IDAPEnquiries@mhra.gov.uk.
Once up-and-running, the IDAP partners will use the lessons
learned from the pilot to help develop the future IDAP pathway,
creating an end-to-end visible framework that supports innovators
generate the evidence they need to achieve regulatory approval,
heath technology assessment decisions, and patient access in the
NHS.
Dr Marc Bailey, MHRA Chief Science and Innovation Officer, said:
“The new IDAP will demonstrate how the UK regulator, health
technology assessment and the healthcare system are working
together to deliver safe, effective, and earlier innovative
medical products to patients, establishing the UK as a centre for
medical innovation.”
“We would welcome early interest from potential applicants, so we
can keep them updated as this key partnership and pathway
develop.”
, Interim Director of medical
technology and digital evaluations at NICE, said:
“We look forward to working with industry to continue the
acceleration of our evaluations and with the MHRA to align our
work for the benefit of patients.”
Dr Susan Myles, Director of Health Technology Wales,
said:
“Now more than ever innovative solutions are needed to address
healthcare challenges. We look forward to working in partnership
with organisations from across the UK to ensure that IDAP helps
to accelerate the development and adoption of these technologies
for the NHS.”
Further information:
To receive further updates on the IDAP, please
email IDAPEnquiries@mhra.gov.uk,
providing your name, organisation name, and email address.
The Medicines and Healthcare products Regulatory Agency (MHRA) is
responsible for regulating all medicines and medical devices in
the UK by ensuring they work and are acceptably safe. All our
work is underpinned by robust and fact-based judgements to ensure
that the benefits justify any risks. The MHRA is an executive
agency of the Department of Health and Social Care.
