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MHRA Update from BIVDA’s 2025 Regulatory Affairs Seminar

BIVDA welcomed Dr Rob Reid and Nadine Neale from the MHRA to BIVDA's Regulatory Affairs Seminar last week. They provided updates on the latest MHRA activity including the MHRA Fees consultation, GB Post Market Surveillance, the Pre-Market SI Consultation, and the AI Airlock Pilot, which members will find useful. We have outlined all updates below: MHRA Fees Consultation – The…
Ben Kemp
February 19, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Update (WC 10 Feb)

Current approaches to product marking Page summary: Guidance on product marking, including the continued recognition of certain EU requirements, such as CE marking, for specific product sectors. Change made: First published. Time updated: 7:00am, 3 February 2025 MHRA asks for views on proposed guidance to support the safe regulation of new personalised cancer therapies   Page summary: The draft MHRA…
Ben Kemp
February 18, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT Updates (WC 10 Feb)

Using harmonised standards for placing CE marked products on the GB market Page summary: If you rely on the continued recognition of EU requirements, including CE marking, and have used a harmonised standard without an identical GB designated standard, you may need to take specific actions. Change made: First published. Time updated: 7:00am, 3 February 2025 Current approaches to product…
Ben Kemp
February 18, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Energy Security and Net Zero Updates (WC 10 Feb)

Current approaches to product marking Page summary: Guidance on product marking, including the continued recognition of certain EU requirements, such as CE marking, for specific product sectors. Change made: First published. Time updated: 7:00am, 3 February 2025 Final UK greenhouse gas emissions statistics: 1990 to 2023 Page summary: Final estimates of UK territorial greenhouse gas emissions. Change made: First published.…
Ben Kemp
February 18, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT Update (WC 10 Feb)

Cyber security codes of practice Page summary: This page brings together the various DSIT codes of practice for cyber security. It explains who they are aimed at and how they align with Cyber Essentials. Change made: Page updated to reflect the new AI Cyber Security Code of practice. Time updated: 12:58pm, 3 February 2025 World-leading AI trial to tackle breast…
Ben Kemp
February 17, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Office for Product Safety and Standards Update (WC 10 Feb)

Designated standards: machinery Page summary: Notices of publication and a consolidated list for designated standards for machinery. Change made: Notice of publication amended and consolidated list updated. Time updated: 2:11pm, 3 February 2025 Safe and sustainable development of advanced materials Page summary: This journal article considers the benefits and barriers to the commercialisation of advanced materials. Change made: First published.…
Ben Kemp
February 17, 2025
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Brexit Update (WC 10 Feb)

Apply to import multiple low value parcels on one declaration Page summary: You can use the bulk import reduced data set to declare one or more low value parcels in a single import declaration when you import goods into Great Britain. Change made: Updated the eligibility information in the sections ‘who can use the bulk import reduced data set’ and…
Ben Kemp
February 17, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT Update (WC 3 Feb)

International AI Safety Report 2025 Page summary: A report on the state of advanced AI capabilities and risks – written by 100 AI experts including representatives nominated by 33 countries and intergovernmental organisations. Change made: First published. Time updated: 1:16pm, 29 January 2025 First International AI Safety Report to inform discussions at AI Action Summit Page summary: First Independent International…
Ben Kemp
February 7, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC Updates (WC 3 Feb)

NHS England annual accountability statement: 2022 to 2023 Page summary: NHS England’s performance measured against the NHS public health functions agreement for 2022 to 2023. Change made: First published. Time updated: 11:04am, 27 January 2025 NHS England annual accountability statements Page summary: NHS England’s performance measured against the NHS public health functions agreement. Change made: First published. Time updated: 11:06am,…
Ben Kemp
February 7, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT Updates (WC 3 Feb)

UK MOUs with US states on economic cooperation and trade relations Page summary: Find out about the memoranda of understanding (MOUs) on cooperation and trade relations the UK has signed with US states. Change made: UK and Colorado trade and economic co-operation memorandum of understanding added to collection. Time updated: 11:59pm, 27 January 2025 UK and Colorado trade and economic…
Ben Kemp
February 7, 2025