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Regulatory Affairs Newsletter

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

DSIT weekly update (WC 04 Sept)

Please note this is an extract of the original bulletin. UK government sets out AI Safety Summit ambitions Page summary: The AI Safety Summit will bring together key countries, technology organisations, academia and civil society. Change made: First published. Industry and national security heavyweights to power UK’s Frontier AI Taskforce Page summary: Leading names from national security to computer science…
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September 15, 2023
FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter Archive

U.S. FDA weekly update (WC 04 Sept)

Please note this is an extract of the original bulletin. FDA Issues Guidance and Requests Comments as a Part of Ongoing Efforts to Modernize the Premarket Notification Program To modernize the 510(k) Program to improve the safety of medical devices, the U.S. Food and Drug Administration (FDA) issued the following three draft guidance intended to support efforts to continue to…
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September 15, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 04 Sept)

Please note this is an extract of the original bulletin. COVID-19 test validation approved products Page summary: Find out which COVID-19 test products have been approved. Change made: Published updated ‘COVID-19 test validation approved products’ MHRA Corporate Plan 2023 to 2026 Page summary: This plan outlines the agency’s strategic direction over the next three years. Change made: This page now…
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September 15, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Cabinet Office weekly update (WC 04 Sept)

Please note this is an extract of the original bulletin. The Border Target Operating Model: August 2023 Page summary: This page contains the Border Target Operating Model, our final plans for a new approach to importing goods into Great Britain, that will be progressively introduced from the end of January 2024. Change made: Added links to risk-levels of commodities from…
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September 15, 2023
Other Updates Regulatory Affairs NewsletterOther Updates Regulatory Affairs Newsletter Archive

Swissmedic weekly update (WC 04 Sept)

Please note this is an extract of the original bulletin. SwissGMDP database Swissmedic is bringing a SwissGMDP database into operation, similar to the European Medicine Agency's (EMA) EudraGMDP database. The SwissGMDP is expected to be launched on the Swissmedic website in the last first quarter of 2024, with the exact date to be announced in the coming months.
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September 15, 2023
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter Archive

Strategic Technology Roadmap for the UK IVD Industry

CPI launched a report at an OLS-supported event in Westminster, earlier this year. This report was the result of a comprehensive set of interviews, workshops as well as broad horizon-scanning through the lens of papers and patents. The report addresses the lack of ecosystem, infrastructure, and funding for IVD companies to remain in the UK and the need for a…
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September 15, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

UK HSA weekly update (WC 11 Sept)

Please note this is an extract of the original bulletin. Point prevalence survey on HCAI, AMU and AMS in England Page summary: A national point prevalence survey on healthcare associated infections (HCAIs), antimicrobial use (AMU) and antimicrobial stewardship (AMS) in England, 2023. Change made: Added training webinar videos and Q&A session details.
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September 15, 2023
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