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Regulatory Affairs Newsletter

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PIC: Export and import of hazardous chemicals

Notifying exports of PIC chemicals for 2026 Companies should notify their exports to HSE as the GB PIC Designated National Authority (DNA) HSE invites companies to submit notifications for exports of chemicals in the GB PIC list that are expected to take place during 2026. The GB PIC Regulation requires the first export of a listed chemical in any calendar…
Ben Kemp
August 14, 2025
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TOPRA Symposium 2025: 30 September – 1 October, and Masterclass

TOPRA are holding their 2025 Symposium in Berlin from 30th September - 1st October. The event promises to cover some of the most important topics affecting IVDs and medical devices, particularly those affecting the EU. You can find the agenda and booking information here. Please find below information related to TOPRA's IVD masterclass later on this year. Regulation of In-Vitro…
Ben Kemp
August 13, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Clinical Trials update – August 2025

New report published on simplified means of seeking and recording consent in clinical trials We’ve published the findings of a survey we ran earlier this year to understand people’s views on using simplified arrangements for consent in certain clinical trials. As part of the updated clinical trials regulations, sponsors will be allowed to use simplified arrangements for obtaining and evidencing…
Ben Kemp
August 6, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Update (WC 4 Aug)

COVID-19 test validation approved products Page summary: Find out which COVID-19 test products have been approved. Change made: Updated ‘Products approved under the Medical Devices Coronavirus Test Device Approvals Amendment Regulations’ CSV file. Time updated: 10:34am, 30 July 2025 Our governance Page summary: The main decision-making, executive and managerial bodies at the Medicines and Healthcare products Regulatory Agency (MHRA). Change…
Ben Kemp
August 6, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Training and events: UKHSA Knowledge and Library Services

Training and events: UKHSA Knowledge and Library Services Page summary: Knowledge and Library Services (KLS) provide a range of information skills training for eligible staff. Training is available in group or one-to-one settings. Change made: Updated training session dates added for August and September. Time updated: 10:16am, 6 August 2025
Ben Kemp
August 6, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT Update (WC 4 Aug)

Smart Data opportunities in digital markets Page summary: We are seeking views on whether and how to introduce a Smart Data scheme in digital markets, using the new powers provided under the Data (Use and Access) Act 2025. Change made: First published. Time updated: 3:00pm, 28 July 2025 Local leaders in every UK nation backed by £30 million each to…
Ben Kemp
August 6, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Brexit Update (WC 4 Aug)

Joint Committee Decisions on the Agreement on the Withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community Page summary: This treaty was presented to Parliament in July 2025. Change made: First published. Time updated: 2:00pm, 31 July 2025 Special Directions made under section 30 of the Customs and…
Ben Kemp
August 6, 2025
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