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

DHSC weekly update (WC 20 Nov)

Please note this is an extract of the original bulletin. Biggest prostate cancer screening trial in decades to start in UK Page summary: The trial will use innovative screening methods like an MRI scan and see hundreds of thousands of men across the country participating Change made: First published. Government response to the review into commercial clinical trials Page summary:…
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December 1, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 13 Nov)

Please note this is an extract of the original bulletin. MHRA authorises world-first gene therapy that aims to cure sickle-cell disease and transfusion-dependent β-thalassemia Page summary: Casgevy (exagamglogene autotemcel) is based on the innovative gene-editing tool CRISPR, which won its inventors the Nobel Prize in 2020 Change made: First published.  
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November 24, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 06 Nov)

Please note this is an extract of the original bulletin. Access Consortium Page summary: The MHRA is part of the Access Consortium along with the Therapeutic Goods Administration, Health Canada, Health Sciences Authority of Singapore and Swissmedic. Change made: Added details of the Access Consortium’s Advanced Therapy Medicinal Products Working Group. Medical devices given exceptional use authorisations during the COVID-19…
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November 17, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 30 Oct)

Please note this is an extract of the original bulletin. The Innovative Devices Access Pathway (IDAP) Page summary: The Innovative Devices Access Pathway (IDAP) program is designed to accelerate the development of cost-effective medical devices and their integration in to the UK market. Change made: Applications for the Innovative Devices Access Programme (IDAP) pilot now closes 1 November 2023 and…
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November 10, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 30 Oct)

Please note this is an extract of the original bulletin. New £100 million fund to capitalise on AI’s game-changing potential in life sciences and healthcare Page summary: A new mission announced by the Prime Minister will accelerate the use of AI in life sciences to tackle the biggest health challenges of our generation. Change made: First published. AI to speed…
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November 10, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 23 Oct)

Please note this is an extract of the original bulletin. Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles Page summary: Guiding principles for the use of Predetermined Change Control Plans (PCCPs) for managing rapid product changes. Change made: First published. MHRA and international partners publish five guiding principles for machine learning-enabled medical devices Page summary: The Medicines…
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November 3, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 09 Oct)

Please note this is an extract of the original bulletin. Government to invest £30 million in innovative technology for NHS* Page summary: Applications are now open for Integrated care systems to apply for a share of £30 million to roll out innovative technology Change made: The press release has been updated as applications are now open for ICSs to bid…
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October 27, 2023
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
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
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