Global standards for Medicines and Medical Devices regulation soon

The MHRA has also been accepted as a member of the US-based Medical Devices Innovation Consortium (MDIC).

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MHRA UK FDA
Picture: QVigilance

Last Updated on June 20, 2022 by The Health Master

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 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.”

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.

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.

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