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Regulatory Affairs Newsletter Archive

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

MHRA weekly update (WC 22 May)

Please note this is an extract of the original bulletin. COVID-19 test approval: how to apply Page summary: How test manufacturers or distributors can apply for approval of their tests to sell on the UK market. Change made: Updated notice on change to the application process. Global AI challenge to investigate veterans’ cardiovascular health launched Page summary: A brand-new challenge…
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May 26, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Submitting Adverse Incidents to Medical Devices to the MHRA – enhancements to the MORE portal

Adverse incidents involving medical devices which occur in the UK are reported to the MHRA via the MORE portal. The MHRA is in the process of implementing several changes to make the MORE portal automatized and easier to use. These updates are expected from June onwards. The MHRA have provided the following information: In our last update, we said that…
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May 26, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 15 May)

Please note this is an extract of the original bulletin. Six new community diagnostic centres to deliver more than 500,000 lifesaving checks a year Page summary: New CDCs to open in regions across the UK, adding to the 106 centres already up and running and helping to cut NHS waiting lists Change made: First published. Health secretary attends Japan summit…
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May 26, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 15 May)

Please note this is an extract of the original bulletin. UK and Japan strengthen science and tech ties in Tokyo Page summary: UK and Japan today signed a renewed science and technology deal, building on decades of close cooperation. Change made: First published. DSIT cyber security newsletter Page summary: A monthly newsletter detailing the latest DSIT announcements, events and projects…
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May 26, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 15 May)

Please note this is an extract of the original bulletin. UK to launch talks with Switzerland on new trade deal Page summary: UK Business and Trade Secretary, Kemi Badenoch, launches negotiations for a modern, updated free trade agreement with Switzerland. Change made: First published. UK-Switzerland enhanced free trade agreement negotiations Page summary: Documents relating to the UK and Switzerland’s negotiations for…
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May 26, 2023
BIVDA updates Regulatory Affairs NewsletterBIVDA Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

BIVDA’s new Regulatory email

BIVDA has recently established a new email address dedicated to handling all regulatory enquiries. If you have any questions, concerns, or require assistance regarding regulatory matters or any events, we kindly ask you to contact our Regulatory Affairs email (Regulatory@bivda.org.uk). This will then be managed by either Ashleigh or Tehelj. If you are awaiting a response to any questions sent…
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May 19, 2023
FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter ArchiveOther Updates Regulatory Affairs NewsletterOther Updates Regulatory Affairs Newsletter Archive

US EPA update (17 May)

Please note this is an extract of the original bulletin. Proposal removes low volume and exposure exemptions for new PFAS and other persistent chemicals, ensuring robust safety review WASHINGTON (May 16, 2023) — Today, the U.S. Environmental Protection Agency (EPA) proposed amendments to the regulations that govern the Agency’s review of new chemicals under the Toxic Substances Control Act (TSCA)…
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May 19, 2023
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