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Regulatory Affairs Newsletter Archive

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The TGA releases compliance principles, reinforcing proactive and risk-based enforcement throughout 2026 and 2027

Dear members, TGA has released their enforcement priorities for 2026-2027, with Direct to consumer IVDs being No. 1 on the list and Software as a Medical Device being No. 7 of the twelve key areas that they intend to focus on. The TGA releases compliance principles, reinforcing proactive and risk-based enforcement throughout 2026 and 2027 The TGA Compliance Principles 2026…
Ben Kemp
February 6, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment) (EU Exit) Regulations (Northern Ireland)

The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment) (EU Exit) Regulations (Northern Ireland) 2026 The Protocol on Ireland / Northern Ireland in the Withdrawal Agreement (“the Protocol”) requires that the EU legislation listed in Annex 2 to that Protocol is implemented in Northern Ireland. Annex 2 includes Regulation (EU) No 528/2012 of the European Parliament and…
Ben Kemp
February 6, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

Countdown to compliance: new UK clinical trial transparency requirements webinar

Countdown to compliance: new UK clinical trial transparency requirements webinar Our Head of Policy and Engagement, Clive Collett, is joining a panel of speakers at a webinar about upcoming changes to research transparency requirements as part of the amended clinical trials regulations. The webinar, organised by Citeline, takes place on Wednesday 25 February from 3pm to 4pm (UK time). Attendees…
Ben Kemp
February 6, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment) (EU Exit) Regulations (Northern Ireland) 2026

The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment) (EU Exit) Regulations (Northern Ireland) 2026 The Protocol on Ireland / Northern Ireland in the Withdrawal Agreement (“the Protocol”) requires that the EU legislation listed in Annex 2 to that Protocol is implemented in Northern Ireland. Annex 2 includes Regulation (EU) No 528/2012 of the European Parliament and…
Ben Kemp
February 6, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT Updates – WC 26th January

Rules of origin changes under the Developing Countries Trading Scheme are now in effect Page summary: This guidance explains improvements to the Developing Countries Trading Scheme (DCTS) rules of origin announced in July 2025. Change made: First published. Time updated: 12:20pm, 19 January 2026 Country Graduation from the Developing Countries Trading Scheme: Indonesia Page summary: This notice sets out the…
Ben Kemp
February 6, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Brexit Updates – WC 26th January

Customs, VAT and excise UK transition legislation from 1 January 2021 Page summary: This collection brings together customs, VAT and excise EU Exit legislation and notices that have the force of law applicable to UK transition. Change made: Added: The Customs (Tariff and Miscellaneous Amendments) Regulations 2026 Time updated: 4:23pm, 20 January 2026 International Recognition Procedure Page summary: How to…
Ben Kemp
February 6, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC Updates – WC 26 January

UK Clinical Research Delivery key performance indicators: data to December 2025 Page summary: Report bringing together data on the delivery of globally competitive clinical research through the UK Clinical Research Delivery programme. Change made: First published. Time updated: 9:30am, 21 January 2026 UK Clinical Research Delivery key performance indicators Page summary: Official statistics in development on the delivery of globally…
Ben Kemp
February 6, 2026
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