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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
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
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 18 Dec)

Please note this is an extract of the original bulletin. The Classification, Labelling and Packaging of Substances and Mixtures (Amendment and Consequential Provision) Regulations 2023 Page summary: This Statutory Instrument makes the necessary legislative amendments to update the statute book by removing references to the revoked Annex VIII of GB Classification, Labelling and Packaging of Substances and Mixtures Regulation. Change…
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January 3, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 18 Dec)

Please note this is an extract of the original bulletin. International Recognition Procedure* Page summary: How to use this new procedure for medicines licensing applications. Change made: Added recording of ‘MHRA International Recognition Webinar November 2023’. *Please note this update does not include medical and IVD devices. Notify the MHRA about a clinical investigation for a medical device Page summary:…
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January 3, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

New MHRA monthly newsletter

The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components for transfusion in the UK. Subscribe to their new monthly newsletter to stay informed on what is going on at the MHRA. MHRA Newsletter December 2023 Please note this is an extract of the original bulletin. Clinical Trials and Investigations Performance The latest MHRA performance data shows…
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January 3, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 11 Dec)

Please note this is an extract of the original bulletin. Consultation on how MHRA communicate with healthcare professionals to improve medicines and medical devices’ safety Page summary: The MHRA is reviewing its approach to engagement with healthcare professionals to improve the safety of medicines and medical devices. Change made: Published Executive summary of consultation and recommendations. COVID-19 test validation approved…
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December 20, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 04 Dec)

Please note this is an extract of the original bulletin. Government response to the review into commercial clinical trials Page summary: The full government response to the Lord O’Shaughnessy independent review of UK commercial clinical trials. Change made: Added Welsh version. New research into expansion of life-saving HIV testing programme Page summary: A new research project has been announced to…
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December 15, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 27 Nov)

Please note this is an extract of the original bulletin. Register medical devices to place on the market Page summary: How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland Change made: Clarification concerning fees and actions required to change legislation of a registered device. The…
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December 8, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 27 Nov)

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: Added a list of hospitals covered by the extension of the HIV opt-out…
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December 8, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 20 Nov)

Please note this is an extract of the original bulletin. International Recognition Procedure* Page summary: How to use this new procedure for medicines licensing applications. Change made: Added guidance on the Eligibility Checker and submitting your Marketing Authorisation application, IRP Product Lifecycle & eCTD guidance for MAs and Lifecycle. MHRA fees* Page summary: Fees payable to the MHRA for 2023…
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December 1, 2023
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