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Regulatory Affairs Newsletter Archive

MHRA publishes a new MedTech roadmap UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA publishes a new MedTech roadmap

The MHRA have published a roadmap towards the future regulatory framework for medical devices. This sets out the relevant timelines into 2025. The roadmap intends to deliver greater international harmonisation, with more patient-centred, proportionate requirements for medical devices which are responsive to technological advances. According to the timelines, MHRA intends to run stakeholder discussions on the future core regulations during the…
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January 9, 2024
NIHR i4i Real World Evidence Programme launched UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

NIHR i4i Real World Evidence Programme launched

The NIHR i4i Programme, in collaboration with the Office for Life Sciences (OLS) and the National Institute for Health and Care Excellence (NICE) are inviting applications to the Real World Evidence Programme. The Real World Evidence Programme is being led by OLS as part of the UK Government’s Life Sciences Vision and is backed by £10m of government funding. The…
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January 9, 2024
DHSC review of the risk of modern slavery in the NHS supply chain UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC review of the risk of modern slavery in the NHS supply chain

The Department of Health and Social Care published a review of the risk of modern slavery in the NHS on 14 December 2023. This was a commitment as part of the amendment to the Health and Social Care Act 2022 by the end of the year. The review was undertaken by NHS England and NHS Supply Chain Coordination Limited scrutinised…
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January 9, 2024
MHRA weekly update (WC 01 Jan) UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 01 Jan)

Please note this is an extract of the original bulletin. MHRA’s new International Recognition Procedure (IRP) goes live from 1 January 2024* Page summary: In partnership with other global regulators, IRP is expected to further help bring life-saving new medicines to UK patients. Change made: First published. *Please note this update does not include medical and IVD devices. Unfettered Access…
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January 9, 2024
DHSC weekly update (WC 01 Jan) UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 01 Jan)

Please note this is an extract of the original bulletin. New research into expansion of life-saving HIV testing programme Page summary: A new research project has been announced to evaluate an expansion of the hugely successful HIV opt-out testing programme to new sites across England. Change made: Updated 5 text references to 46 new hospitals, correcting to 47; amended ‘New…
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January 9, 2024
DBT weekly update (WC 01 Jan) UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 01 Jan)

Please note this is an extract of the original bulletin. The Retained EU Law (Revocation and Reform) Act 2023 (Consequential Amendment) Regulations 2023 Page summary: The Instrument will implement the relabelling of Retained EU Law (REUL) (and related terms) as “assimilated law” (and related terms) in primary legislation. Change made: Statutory Instrument sent to sift and Explanatory Memorandum sent to…
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January 9, 2024