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Regulatory Affairs Newsletter Archive

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

Clinical trials regulations: six-month countdown begins

A new post, “Clinical trials regulations: six-month countdown begins” has just been published on the MedRegs blog. In six months’ time, on 28 April 2026, the most significant update to UK clinical trials regulations in two decades will come into force. This will be a pivotal moment for the evolving clinical trial landscape and marks a new … Read the…
Ben Kemp
October 31, 2025
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EU CMR Classification of Ethanol under BPR

Dear members, please see below update on the proposed CMR Classification of Ethanol under EU Biocidal Products Regulation. This would impact Northern Ireland as well as the EU, and would impact the use of ethanol as a disinfectant. Background: Ethanol is currently undergoing a parallel evaluation as a biocidal active substance under the Biocidal Product Regulation and for harmonised classification…
Ben Kemp
October 31, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

EM on EU Regulation 2025/637 amending 2022/2292 (COM(2025)518)

EM on EU Regulation 2025/637 amending 2022/2292 (COM(2025)518) Page summary: The government’s summary of an EU Commission Delegated Regulation 2025/637 with regards to entry into the Union of certain animal-derived products. Change made: First published. Time updated: 6:16pm, 24 October 2025
Ben Kemp
October 31, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DEFRA Updates (WC 27 October)

Packaging data: check reporting periods and submission deadlines Page summary: Find out when large and small organisations affected by Extended Producer Responsibility for packaging (EPR) must collect and submit packaging data. Change made: Updating deadline information for the next reporting period, including information about registration deadlines. Time updated: 3:02pm, 20 October 2025 New financial penalties for environmental offences Page summary:…
Ben Kemp
October 31, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Find a professional to certify export health certificates

Find a professional to certify export health certificates Page summary: A list of organisations in England, Scotland and Wales that inspect and certify animals and animal products for export. The list does not include every certifier. Change made: Updated the list of professionals who can certify export health certificates in England. Time updated: 4:12pm, 23 October 2025
Ben Kemp
October 31, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT Updates (WC 27th October)

UK regions given extra £20m science and tech cash boost as new investment kicks off landmark growth summit Page summary: Greater Manchester, West Midlands and Glasgow City Region backed with £50m each to support local innovation priorities, plus £30m life sci investment unlocked Change made: First published. Time updated: 12:01am, 19 October 2025 UK-Sweden Memorandum of Understanding for cooperation in…
Ben Kemp
October 31, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT Updates (WC 27 October)

UK-Central America committee documents Page summary: Decisions, documents and meeting minutes from UK-Central America countries committees. Change made: ‘12 November 2024: Joint minutes of the second meeting of the UK-Central America customs, trade facilitation and rules of origin sub-committee’ added to page. Time updated: 10:55am, 20 October 2025 Western Balkans Summit Economy Ministers' meeting: 16 October 2025 Page summary: This…
Ben Kemp
October 31, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC Updates (WC 27 October)

Major NHS update brings menopause into routine health checks Page summary: Menopause advice will be added to free health checks to help millions of women get the care they need. Change made: First published. Time updated: 12:01am, 23 October 2025 Advances in science set to transform treatments for people living with dementia Page summary: From blood tests to AI, new…
Ben Kemp
October 31, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Updates (WC 27 October)

Medical devices given exceptional use authorisations Page summary: List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled. Change made: Updated – ‘List of medical devices given exceptional use authorisations’: (DEU/008/2022/015) 10 April 2026 – Extension issued Time updated: 10:49am, 21 October 2025 Government cuts red tape…
Ben Kemp
October 31, 2025
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Updated information for BSI clients on Periodic Safety Update Reports (PSURs)

Following legislation amendments (EU)2023/607, (EU)2024/1860 and new PMS regulations applicable in Great Britain, BSI is providing updated information on PSUR. Topics covered in this communication: BSI PSUR evaluation process and PSUR submission timelines Combined reviews of PSUR under EU regulations and UK MDR PMS requirements for Great Britain PSURs for legacy devices placed on the market under the Directives PSUR…
Ben Kemp
October 31, 2025
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