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Regulatory Affairs Newsletter Archive

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

MHRA weekly update (WC 02 Oct)

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: The 'COVID-19 test validation approved products' file has been updated. International Recognition Procedure* Page summary: How to use this new procedure for medicines licensing applications. Change made: The webinar recording has been…
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October 13, 2023
FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter Archive

U.S. FDA weekly update (WC 25 Sept)

FDA Proposes Rule Aimed at Helping to Ensure Safety and Effectiveness of Laboratory Developed Tests | FDA On September 29, the U.S. Food and Drug Administration (FDA) announced a proposed rule which aims to end enforcement discretion on Laboratory Device Tests (LDTs). This means, under this proposed rule, that LDTs will be regulated a medical device and it will be…
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October 6, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 25 Sept)

Please note this is an extract of the original bulletin. The Northern Ireland MHRA Authorised Route (NIMAR)* Page summary: The UK government has introduced the Northern Ireland MHRA Authorised Route (NIMAR). This new route for supply became operational 1 January 2022. Change made: Information added about transitional arrangements for licences associated with the implementation of the Windsor Framework and links…
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October 6, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 25 Sept)

Please note this is an extract of the original bulletin. UK signs sixth US state deal with Washington State Page summary: The UK and the US state of Washington will today sign a new Memorandum of Understanding (MoU) to boost trade and investment. Change made: First published. Notices to exporters Page summary: Notices to exporters published by the Export Control…
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October 6, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Cabinet Office weekly update (WC 25 Sept)

Please note this is an extract of the original bulletin. Smarter regulation Page summary: This page sets out how the UK government’s smarter regulation programme seeks to reduce burdens on businesses and promote innovation and growth. Change made: New section added for ‘Calls for evidence’. ‘Package travel legislation: updating the framework’ and ‘Smarter regulation non-financial reporting review: call for evidence’links…
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October 6, 2023
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