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Regulatory Affairs Newsletter

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U.S. FDA weekly update (WC 24 July)

Please note this is an extract of the original bulletin. For In Vitro Diagnostic Test Developers: Updates to the FDA’s Clinical Laboratory Improvement Amendments (CLIA) Web pages Make Processes Clearer, Easier to Understand The Clinical Laboratory Improvement Amendments (CLIA) and the associated regulations provide the authority for oversight of clinical laboratories and laboratory testing. While the Centers for Medicare and…
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August 4, 2023
Other Updates Regulatory Affairs NewsletterOther Updates Regulatory Affairs Newsletter Archive

Swissmedic weekly update (WC 24 July)

Please note this is an extract of the original bulletin. MRA between Switzerland and the USA on the manufacturing practice for medicinal products takes effect Mutual recognition in principle of inspections by Swissmedic and the FDA. The Mutual Recognition Agreement (MRA) between Switzerland and the United States in the area of Good Manufacturing Practice (GMP) for medicinal products signed in…
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August 4, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Extension of CE mark recognition in Great Britain for certain products

The UK Government have announced that recognition of the CE mark for most goods will be continued indefinitely, beyond December 2024. This applies only to the 18 regulations falling under the Department for Business and Trade (DBT), covering a range of products: toys pyrotechnics recreational craft and personal watercraft simple pressure vessels electromagnetic compatibility non-automatic weighing instruments measuring instruments measuring…
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August 4, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 17 July)

Please note this is an extract of the original bulletin. Foreign Secretary to call for international cooperation to manage the global implications of Artificial Intelligence Page summary: Foreign Secretary James Cleverly will chair first ever United Nations Security Council (UNSC) session on Artificial Intelligence (AI). Change made: Link to the Foreign Secretary’s speech at the UN Security Council added. Engineering…
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July 28, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 17 July)

Please note this is an extract of the original bulletin. Boost for women and girls as Women’s Health Strategy turns one Page summary: A year on from its Women’s Health Strategy, the government has announced a package of new measures to boost the health and wellbeing of women and girls. Change made: First published. Women's health hubs: information and guidance…
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July 28, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 17 June)

Please note this is an extract of the original bulletin. New lung cancer screening roll out to detect cancer sooner Page summary: National targeted lung cancer screening programme designed to catch cancer sooner announced Change made: First published. Health Secretary's Oral Statement on lung cancer screening Page summary: Health and Social Care Secretary Steve Barclay delivered an Oral Statement on…
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July 28, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 17 July)

Please note this is an extract of the original bulletin. CPTPP: investment report Page summary: Information on businesses from Comprehensive and Progressive Trans-Pacific Partnership (CPTPP) countries and their contribution to the UK economy. Change made: First published. UK signs treaty to join vast Indo-Pacific trade group as new data shows major economic benefits Page summary: Business and Trade Secretary Kemi…
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July 28, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 17 July)

Please note this is an extract of the original bulletin. In vitro diagnostic medical devices: guidance on legislation Page summary: Guidance explaining the main features of the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) in relation to in vitro diagnostic medical devices Change made: In vitro diagnostic medical devices: guidance on legislation file updated. How tests and testing…
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July 28, 2023
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