Regulatory Affairs Newsletter Archive – Page 138

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APHA weekly update (WC 08 Jan)

Please note this is an extract of the original bulletin. Export blood and blood products for technical use to Turkey: certificate 8136 updated Page summary: Apply online to export animal blood and blood products for uses other than human or animal consumption to the Republic of Turkey. Change made: Updated NFG Animal by-product operating plants: approved premises Page summary: Details…

adminJanuary 17, 2024

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DSIT weekly update (WC 08 Jan)

Please note this is an extract of the original bulletin. Turing Artificial Intelligence Fellowships Page summary: The Turing AI Fellowships are a £46 million initiative created by the UK government, aimed at attracting and maintaining the best talent in artificial intelligence. Change made: Two new Turing AI fellows – Professor Alison Noble and Professor Michael Bronstein were awarded Turing AI…

adminJanuary 17, 2024

OPSS weekly update (WC 08 Jan)

Please note this is an extract of the original bulletin. Regulations: consumer connectable product security Page summary: Guidance for manufacturers, importers and distributors. Change made: First published. Approved manufacturers: conformity assessment Page summary: Apply to become or identify an approved manufacturer authorised to carry out conformity assessment. Change made: List of approved manufacturers updated. Approved verification: guidance and application form…

adminJanuary 17, 2024

Office for Life Sciences – publications (WC 08 Jan)

The Office for Life Sciences have published their latest updates. OLS stakeholder bulletin - 12 January These include updates on news, including regulatory updates, transitional guidance and events.

adminJanuary 17, 2024

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EU proposed position on intellectual property of genetic resources and traditional knowledge with genetic resources

A recommendation is put forth for Council Decision authorizing the initiation of negotiations on an international legal instrument regarding intellectual property, genetic resources, and traditional knowledge associated with genetic resources. The proposal provides an explanatory memorandum that outlines the context, legal elements, and Union competence for the recommendation.

adminJanuary 17, 2024

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MHRA publishes a new MedTech roadmap

The MHRA have published a roadmap towards the future regulatory framework for medical devices. This sets out the relevant timelines into 2025. The roadmap intends to deliver greater international harmonisation, with more patient-centred, proportionate requirements for medical devices which are responsive to technological advances. According to the timelines, MHRA intends to run stakeholder discussions on the future core regulations during the…

adminJanuary 9, 2024

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NIHR i4i Real World Evidence Programme launched

The NIHR i4i Programme, in collaboration with the Office for Life Sciences (OLS) and the National Institute for Health and Care Excellence (NICE) are inviting applications to the Real World Evidence Programme. The Real World Evidence Programme is being led by OLS as part of the UK Government’s Life Sciences Vision and is backed by £10m of government funding. The…

adminJanuary 9, 2024

Office for Life Sciences – publications (WC 01 Jan)

The Office for Life Sciences have published their latest updates. OLS stakeholder bulletin - 05 January These include updates on news, including regulatory updates, transitional guidance and events.

adminJanuary 9, 2024

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DHSC review of the risk of modern slavery in the NHS supply chain

The Department of Health and Social Care published a review of the risk of modern slavery in the NHS on 14 December 2023. This was a commitment as part of the amendment to the Health and Social Care Act 2022 by the end of the year. The review was undertaken by NHS England and NHS Supply Chain Coordination Limited scrutinised…

adminJanuary 9, 2024

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MHRA weekly update (WC 01 Jan)

Please note this is an extract of the original bulletin. MHRA’s new International Recognition Procedure (IRP) goes live from 1 January 2024* Page summary: In partnership with other global regulators, IRP is expected to further help bring life-saving new medicines to UK patients. Change made: First published. *Please note this update does not include medical and IVD devices. Unfettered Access…

adminJanuary 9, 2024