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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
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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
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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
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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
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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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ISO 13485:2016 reconfirmed

Please be advised that ISO TC210 have reconfirmed ISO13485:2016 until 2030. Note that ISO 9000 QMS – fundamentals and vocabulary will be updated to ISO9000:2026 and this will have a impact on ISO13485 as a normative reference, but the core requirements of ISO 13485:2016 will remain.
Ben Kemp
October 31, 2025
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The Registrar of Companies (Fees) (Amendment) Regulations 2025

The Registrar of Companies (Fees) (Amendment) Regulations 2025 These Regulations amend the Registrar of Companies (Fees) (Companies, Overseas Companies and Limited Liability Partnerships) Regulations 2012 (S.I. 2012/1907) (“the 2012 Regulations”), the Registrar of Companies (Fees) (Registrar of Overseas Entities) Regulations 2024 (“the 2024 Regulations”), the Registrar of Companies (Fees) (Limited Partnerships and Newspaper Proprietors) Regulations 2009 (S.I. 2009/2392) (“the 2009…
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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