The UK will play 'a greater international role' in ensuring medicines and medical devices are 'regulated safely and efficiently worldwide,' the Medicines and Healthcare products Regulatory Agency (MHRA) has announced, after being accepted as a member of three global partnerships.
Both IMDRF and ICH are 'focused on improving the harmonisation and convergence of medicines and medical devices regulation globally,' MHRA explained.
Through these partnerships, MHRA said it 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.'
Before the UK’s exit from the EU in January 2020, 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.
The ICH brings together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines.
'ICH's mission is to achieve greater harmonisation worldwide to ensure that safe, effective and high-quality medicines are developed, and registered and maintained in the most resource efficient manner whilst meeting high standards,' it said.
The IMDRF is 'a voluntary group of medical device regulators from around the world' who aim to 'accelerate international medical device regulatory harmonisation and convergence,' the IMDRF explained.
The IMDRF Strategic Plan 2021-2025 has three priority areas:
- Pre-Market - Develop a risk calibrated regulatory approach for innovations and promote harmonised pre-market review requirements for medical devices
- Post-Market - Leverage post-market monitoring and surveillance to ensure accessibility to safe and effective innovations for patients
- Relationships with Stakeholders - Continue to promote close communication about IMDRF activities and outputs with stakeholders
The MHRA has also been accepted as a full member of the US-based Medical Devices Innovation Consortium (MDIC) - a public-private partnership that 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,' MDIC explained.
Dr Glenn Wells, chief international and partnerships officer at 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.'
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