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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

DHSC Update (WC 4 Aug)

10 Year Health Plan for England: fit for the future Page summary: Sets out the government’s 10 Year Health Plan for England. Change made: Updated ‘Fit for the future: 10 Year Health Plan for England – executive summary’ to include the first edit on the correction slip in the full 10 Year Health Plan. Time updated: 9:29am, 30 July 2025…
Ben Kemp
August 6, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Clinical Trials hub is now live – it contains draft guidance

The MHRA Clinical Trials hub on GOV.UK contains draft guidance to support the implementation of the new Clinical Trials Regulations set to come into effect on 28 April 2026. Where appropriate, we have included links to the Health Research Authority’s (HRA) guidance. We promoted the new draft guidance to a small group of interested and involved members of the clinical…
Ben Kemp
August 6, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Biocides: New EU active substance approval and non-approval decisions

New EU active substance approval decisions Apply for product authorisation by the deadline to keep your products on the NI market. Following evaluation under the EU Biocidal Products Regulation (EU BPR), a decision has been taken to approve the following active substance/product type combinations. This will affect NI: 1 February 2027 Peracetic acid generated from 1,3-diacetyloxypropan-2-yl acetate and hydrogen peroxide…
Ben Kemp
August 6, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Radio equipment regulations

Radio equipment regulations Page summary: Guidance for businesses on the Radio Equipment Regulations 2017 and Radio Equipment (Amendment) (Northern Ireland) Regulations 2024. Change made: Factsheet added on Regulation (EU) 2022/30, introducing additional mandatory cybersecurity essential requirements for certain categories of radio equipment placed on the market from 1 August 2025. Time updated: 11:00am, 1 August 2025
Ben Kemp
August 6, 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 31 07 25

PHES Maintenance – 4 August 25 The PHES (Plant Health Export Service) will be unavailable due to planned maintenance on Monday, 4 August 2025, between 6:30 PM – 10:00 PM. During this time, you will be unable to access the services. Normal service should resume from 10 PM onwards. Apologies for any inconvenience caused. Clarification on safeguard measures for low-risk…
Ben Kemp
August 6, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

HRA Now – further updates to the commercial agreements for participating NHS and HSC organisations

What: the commercial model agreements for use with participating NHS and HSC organisations have been updated to align with the model Commercial Chief Investigator Agreements published in June 2025 Who: commercial sponsors, contract research organisations (CROs), NHS and HSC organisations Where: UK wide (England, Northern Ireland, Scotland and Wales) When: Wednesday 30 July 2025 The following suite of commercial model…
Ben Kemp
August 4, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Persistent Organic Pollutants – Defra/DHSC/Trade Associations

Dear members, following a recent DEFRA/DHSC joint briefing on the UN Stockholm Convention (Persistent Organic Pollutants), please see this slide deck which maps out the process at international and national implementation. DHSC and DEFRA are particularly interested in member engagement of Socioeconomic impacts of implementation, especially with regard to what evidence members have of impact where longer transition timelines are…
Ben Kemp
August 4, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

CELEX:32025R1561: Regulation (EU) 2025/1561 of the European Parliament and of the Council of 18 July 2025 amending Regulation (EU) 2023/1542 as regards obligations of economic operators concerning battery due diligence policies

The European Commission have published the below legislation to delay the implication dates of certain requirements under the Batteries and Batteries Waste Due Diligence requirements. Regulation (EU) 2025/1561 of the European Parliament and of the Council of 18 July 2025 amending Regulation (EU) 2023/1542 as regards obligations of economic operators concerning battery due diligence policies (Text with EEA relevance) View…
Ben Kemp
August 4, 2025
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

PUBLISHED – MedTech Europe reflection paper on Sampling under IVDR

Dear Members, MedTech Europe have published the reflection paper on Notified Body Sampling of technical files under the IVDR. This is part of the work that MedTech Europe is under taking to look at reducing administrative burden as part of the review of the implementation of the IVDR. You can find the published document on MedTech Europe website here: https://www.medtecheurope.org/news-and-events/news/sampling-under-in-vitro-diagnostics-regulation-medtech-europe-proposal-for-a-more-risk-based-approach/…
Ben Kemp
August 4, 2025
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