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Regulatory Affairs Newsletter Archive

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HSE safety notice – risk of exposure of laboratory staff to biological agents

Risk of exposure of laboratory staff to biological agents Since the publication of our safety notice last year, HSE has continued receiving a high number of Dangerous Occurrences reported under RIDDOR from diagnostic laboratories. Communication failures of relevant clinical information to laboratories are leading to the exposure of laboratory staff to high hazard biological agents. With this in mind, please…
Ben Kemp
November 13, 2025
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Health preparedness: EU reference laboratories improve disease surveillance data

Health preparedness: EU reference laboratories improve disease surveillance data On EU Lab Day, the European Commission marks one year of improved coordination on surveillance data thanks to the EU reference laboratories (EURLs). This is part of the Commission’s work to coordinate robust preparedness, early warning and response mechanisms for health crises, as part of a strong European Health Union. The…
Ben Kemp
November 6, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

IPO fees to increase from 1 April 2026

IPO fees to increase from 1 April 2026 The Intellectual Property Office (IPO) is increasing fees for patents, trade marks and designs from 1 April 2026, subject to parliamentary approval. The current fees will remain in place until then. The IPO have not increased fees for a number of years and this will allow us to continue to provide high…
Ben Kemp
November 6, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

[CORRECTION] Countering Russian sanctions evasion: guidance for the freight & shipping sector

Today, the Office of Trade Sanctions Implementation has published new guidance on countering Russian sanctions evasion targeted specifically at businesses operating in the freight and shipping sector.  This guidance is intended to help businesses in the freight and shipping sector understand Russian circumvention practices and reduce their risk of being targeted by those seeking to evade sanctions. It contains:   information on…
Ben Kemp
November 6, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Update from GOV.UK for: Register medical devices to place on the market

Register medical devices to place on the market Page summary: How to register your medical devices with the MHRA for the markets in Great Britain and Northern Ireland. Change made: Updated fees implementation and management guidance, to correct minor typos only, no change to content.Updated link to survey on fees implementation and management guidance Time updated: 3:52pm, 5 November 2025
Ben Kemp
November 6, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

SRD Industry Newsletter

Medicines Supply Security Committee Inquiry   The Public Services Select Committee is carrying out an inquiry to understand the causes of medical shortages and the ability to predict and prevent medicine shortages that are currently putting significant pressure on the Health Sector. These shortages impact the direct health of patients and put the NHS, Pharmacies and GPs under increased pressure. The aim of…
Ben Kemp
November 6, 2025
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TGA releases updated social media advertising guidance to support improved compliance

The Therapeutic Goods Administration (TGA) has updated its Advertising therapeutic goods on social media guidance to help advertisers to understand their responsibilities when promoting therapeutic goods via these platforms. While social media offers powerful opportunities for consumer engagement, any content that promotes the use or supply of therapeutic goods is considered advertising and must comply with regulatory requirements under the Therapeutic Goods…
Ben Kemp
November 6, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

ISO TC 210 Working group

Dear members, following on from the good news that ISO TC 210 WG had reconfirmed ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes, meaning that it remains unchanged until April 2030, two other updates have been received. The guidance on the implementation of ISO 13485 will be updated and released as ISO TS 23485 in…
Ben Kemp
November 6, 2025
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Reminder – Moving to a single list for UK sanctions designations

Reminder - Moving to a single list for UK sanctions designations - 28 January 2026 The OFSI Consolidated List of Asset Freeze Targets is closing. From 09:00 GMT on Wednesday 28 January 2026 the UK Sanctions List will be the only source for all UK sanctions designations. There will be no changes to the structure of the current UK Sanctions List. Guidance has been published…
Ben Kemp
November 6, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Abiraterone recommendation could save NHS millions

The NHS has published final draft guidance recommending abiraterone and its generic variants in combination with androgen deprivation therapy and prednisolone or prednisone as an option for adults with newly diagnosed high-risk hormone‑sensitive metastatic prostate cancer. The decision marks a significant shift from our 2021 guidance, which could not recommend abiraterone because, at the time, it did not represent value…
Ben Kemp
November 6, 2025
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