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Regulatory Affairs Newsletter

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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 13, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory 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 13, 2025
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Improve your URRA with Expert Advice

Open Forum: Use-Related Risk Analysis Q&A   Tuesday ,Nov, 18, 2025 | 9:00 AM - 10:00 AM CST Join our subject matter experts, Merrick Kossack, senior research director; Frauke Schuurkamp, managing human factors specialist; and Rachel Aronchick, managing human factors specialist, from Emergo by UL’s Human Factors Research & Design team on Nov. 18, 2025, from 9–10 a.m. CST for…
Ben Kemp
November 13, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

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
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

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
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

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
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