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Ben Kemp

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

The Customs (Miscellaneous Amendments) Regulations 2025

Please not the changes being made to UK customs regulations, include postal packet and universal package services, including for items declared as temporarily being in the UK. The Customs (Miscellaneous Amendments) Regulations 2025 This instrument contains various amendments to Customs secondary legislation made under the Taxation (Cross-border Trade) Act 2018 (c. 22) (“TCTA”), and amendments to the Postal Packets (Revenue…
Ben Kemp
July 4, 2025
FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter ArchiveIndustry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

FDA reclassifications

Please note that this consultation closes 11th August 2025. The Food and Drug Administration (FDA) is proposing to reclassify in situ hybridization (ISH) test systems indicated for use with a corresponding approved oncology therapeutic product (product codes NYQ, MVD, OWE, and PNK) from class III (premarket approval) into class II (special controls), subject to premarket notification. FDA is also proposing…
Ben Kemp
July 4, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Biocides: GB active substance renewal submission deadlines

Apply for active substance renewal by the deadlines to keep products on the GB market. Under the GB Biocidal Products Regulation (GB BPR), active substance approvals will expire unless a renewal application is submitted at least 550 days before their expiry date. The 550-day deadlines are coming up for the following active substance/product type combinations under GB BPR: 27 December…
Ben Kemp
July 4, 2025
ConsultationsConsultations ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Clinical Trials update – June 2025

UK Health Research Authority are requesting feedback by 10th September on guidance to the new Clinical Trials Regulation. Note that the new regulation applies to medicinal products, however clinical trials involving combination products, or using IVDs are in scope, although you have to hunt through the Guidance and find the reference to: Combined trials of an investigational medicinal product and…
Ben Kemp
July 4, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

FDA Consensus Standards – Updated 20250526

Please see this list of FDA consensus standards (updated last month). Of note are the items below including AAMI TIR45 on AGILE practices in software development, and the updated Common Vulnerability Scoring System  (CVSS), noting that both 3.1 and 4.0 are recognised, but that the period for which 3.1 is recognised is 7 months then 4.0 is recognised. As usual,…
Ben Kemp
July 4, 2025
Membership NewsMembership News Archive

NHS Ten Year Plan Expected 3rd July

The much-awaited NHS Ten Year Plan is due to be released tomorrow. A flurry of briefings over the weekend have given clues on what to expect, with a focus on staff reform, revised funding models, and the use of digitalisation to speed up delivery. Areas of particular interest to the IVD industry include “innovator passports” designed to speed up adoption…
Ben Kemp
July 2, 2025
HighlightsHighlights Archive

Media Monitoring: 26th June – 2nd July

  New DSIT Permanent Secretary appointed Emran Mian has been appointed as the new Permanent Secretary at the Department for Science, Innovation and Technology, replacing Sarah Munby Emran is currently Director General for Digital Technologies and Telecoms at DSIT, where he is responsible for programmes to make the UK one of the best places in the world to undertake AI…
Ben Kemp
July 1, 2025
HighlightsHighlights Archive

UK researchers to create synthetic human genomes

A team of UK-based scientists are developing technology to create the first synthetic human chromosome. The ability to write large genomes has the potential to transform our understanding of human health, opening opportunities to develop cell therapies, climate-resistant crops and more. The Wellcome Trust is providing £10 million funding to the new Synthetic Human Genome Project (SynHG) to develop the foundational…
Ben Kemp
July 1, 2025
HighlightsHighlights ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA publishes 2025 Business Plan

The Medicines and Healthcare products Regulatory Agency (MHRA) has published its Business Plan for 2025/26, reaffirming its commitment to keeping patients safe and enabling access to high quality and effective medical products through innovation across the UK. The plan appears forward-looking, acknowledging their purpose as an engine of economic growth and the need to be bold and ambitious in the…
Ben Kemp
July 1, 2025
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