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Regulatory Affairs Newsletter

Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

HRA Now – updates to model agreements

Dear members, UK Health Research Authority has updated a number of its model clinical trial agreements as below, and the new versions will apply to trials in all four nations (England, Wales, Scotland, and Northern Ireland) from 28th April 2025. IRAS Help - Preparing & submitting applications - Templates for supporting documents
Ben Kemp
May 1, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Science, Innovation and Technology Updates (WC 28 April)

AI-assisted vs human-only evidence review Page summary: An exercise to investigate the robustness and reliability of using generative AI to help produce evidence reviews, compared to those only using human input. Change made: First published. Time updated: 10:00am, 23 April 2025 UK-Japan data adequacy: joint statement Page summary: Joint statement from a meeting with Commissioner Shuhei Ohshima and Chris Bryant.…
Ben Kemp
May 1, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department of Health and Social Care Updates (WC 28 April)

Shaping the national cancer plan (easy read) Page summary: We want to hear your ideas about how to make cancer care better for everyone. Your ideas will help the government to make a national cancer plan for England. Change made: First published. Time updated: 2:00pm, 22 April 2025 New DHSC Permanent Secretary Appointed Page summary: Samantha Jones has been appointed…
Ben Kemp
May 1, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Brexit Updates (WC 28 April)

Health professionals and pharmaceutical products (VAT Notice 701/57) Page summary: How to account for VAT on goods and services provided by registered health professionals, including doctors, dentists, nurses and pharmacists. Change made: Section ‘3.5 Personal protective equipment (PPE)’ has been removed as the VAT zero rate stopped on 1 November 2020. Section ‘4.1 Access to medical records’ has been updated…
Ben Kemp
April 30, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT Updates (WC 28 April)

Trade and investment core statistics book Page summary: A monthly snapshot of the UK’s trade and investment position, summarising trade statistics produced by ONS, HMRC, DBT and others. Change made: Trade and investment core statistics book updated with latest statistical data Time updated: 9:30am, 22 April 2025 UK trade in numbers Page summary: A snapshot of the UK’s latest trade…
Ben Kemp
April 30, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

APHA – Border Trade Newsletter – getting it right at the border 24 04 25

Dear Members, please note the ability for EU exporters to use voluntary import declarations for shipments coming into the UK from 30th April 2025. See the APHA update below.   Getting it right at the border  This newsletter from the Animal and Plant Health Agency (APHA) covers the latest operational updates on requirements and border controls for importing live animals,…
Ben Kemp
April 30, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

FW: CELEX:32025D0799: Council Decision (EU) 2025/799 of 14 April 2025 establishing the position to be taken on behalf of the European Union within the Joint Committee established by the Agreement on the withdrawal of the United Kingdom of Great Britain an

Please see the EU position to include Regulation (EU) 2024/2847 of the European Parliament and of the Council of 23 October 2024 on horizontal cybersecurity requirements for products with digital elements and amending Regulations (EU) No 168/2013 and (EU) 2019/1020 and Directive (EU) 2020/1828 (Cyber Resilience Act), with the exception of Articles 5 and 67 thereof, shall be added to Annex 2 to the…
Ben Kemp
April 30, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

NANDO update – 2 new Notified Bodies for IVDR added

Dear Members, not one, but two new notified bodies designated under the EU IVD Regulation 2017/746 and added to NANDO: SGS Belgium NV and IMQ Instituto Italiano Del Marchio Di Qulaita S.P.A Italy This makes it 16 Notified Bodies so far, out of the 22 applications. As always, if interested in using these new notified bodies you need to check…
Ben Kemp
April 30, 2025
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