The UK is set to play a greater international role in making sure
medicines and medical devices are regulated safely and
efficiently worldwide, the Medicines and Healthcare products
Regulatory Agency (MHRA) announced today after being accepted as
a full member of three international work-sharing partnerships.
Two of these, the International Medical Device
Regulatory Forum (IMDRF) and the International Council for
Harmonisation of Technical Requirements for Pharmaceuticals for
Human Use (ICH) are focused on improving the harmonisation
and convergence of medicines and medical devices regulation
globally.
Through these partnerships, the MHRA will share expertise with
other leading organisations, support the development of
regulatory guidelines and drive greater harmonisation of
regulation around the world. This will help deliver timely access
to innovative medical products not just in the UK but globally.
The MHRA has also been accepted as a member of the US-based
Medical
Devices Innovation Consortium (MDIC). This public-private
partnership brings together representatives of regulatory bodies,
industry, non-profits, and patient organisations from different
countries to improve the processes for development, assessment,
and review of new medical technologies. This enables
transformational medical technology to get to the people who need
it sooner, by shortening the path from innovation to safety to
access.
Dr Glenn Wells, Chief International and Partnerships
Officer at the MHRA, said:
“We are delighted to join these three international organisations
to collaborate on regulatory alignment that will help deliver
safer, innovative, and more cost-effective medicines and medical
devices to the people who need them sooner.
“We are currently building a world-leading regime for regulating
medicines and medical devices in the UK that prioritises patient
safety while fostering innovation, and we look forward to sharing
expertise with partner organisations for the benefit of patients
not just in the UK but worldwide.”
Notes to editors
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The MHRA is one of the world’s leading regulators of
medicines, medical devices, and blood components for
transfusion. Recognised globally as an authority in its
field, the agency plays a leading role in protecting and
improving public health and supports innovation through
scientific research and development.
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Before the UK’s exit from the EU, the MHRA was part of both
the IMDRF and ICH under the EU system, became observer
nations after Brexit, and is now a full sovereign member.
