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Regulatory Affairs Newsletter

Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Animal and Plant Health Agency Updates (WC 26th May)

Single case of atypical BSE confirmed on a farm in Essex Page summary: A single case of atypical Bovine Spongiform Encephalopathy (BSE) has been confirmed on a farm in Essex, the Animal and Plant Health Agency (APHA) confirmed today (Tuesday 20 May). Change made: First published. Time updated: 10:37am, 20 May 2025 Export other mammals to Northern Ireland: certificate 9110 updated…
Ben Kemp
May 28, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Policy papers and consultations with organisations of Animal and Plant Health Agency, Department for Environment, Food & Rural Affairs, Medicines and Healthcare products Regulatory Agency, and Office for Product Safety

Government response to OEP review: implementation of the duty to have due regard to the Environmental Principles Policy Statement Page summary: The government’s response to the Office for Environmental Protection review of the duty to have due regard to the Environmental Principles Policy Statement. Change made: First published. Time updated: 10:45am, 19 May 2025 MHRA draft guideline on the use…
Ben Kemp
May 28, 2025
Other Updates Regulatory Affairs NewsletterOther Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

New from CLSI: POCT16, 1st Edition Emergency and Disaster Point-of-Care Testing

Just Published! POCT16, 1st Edition Emergency and Disaster Point-of-Care Testing   In crises, every second counts. CLSI POCT16 delivers practical, step-by-step guidance for using point-of-care testing (POCT) devices in emergency, disaster, and urgent care settings—helping teams respond faster, more effectively, and with confidence.   Streamlined protocols for high-stress environments Improve patient care during disasters and outbreaks Support regulatory readiness and…
Ben Kemp
May 28, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Swissmedic have updated their guidance on vigilance reporting to reflect the EU introduction of MIR form ver 7.3.1

Swissmedic have updated their guidance on vigilance reporting to reflect the EU introduction of MIR form ver 7.3.1 - www.bivda.org.uk/Portals/0/documents/Regulatory-Affairs/Misc%20docs/MU680_20_815e_WL_Guide_MIR_Manufacturer_Incident_Report_for_CH.pdf?ver=raJA0C2t47BhEDn4xJaWDA%3d%3d
Ben Kemp
May 23, 2025
Other Updates Regulatory Affairs NewsletterOther Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

WHO webinar: New guidance on WHO post-prequalification and post-EUL listing change applications for IVDs

WHO recently published a revised guidance and application form for reporting changes to WHO prequalified and emergency use listed in vitro diagnostic (IVD) products. A webinar introducing the new guidance took place on 19 May 2025 and gathered over 120 participants. If you couldn’t attend the webinar but are interested in this subject, please access the webinar recording https://who.zoom.us/rec/share/omC-19wYnD1iXMZtP_qbYNmvfEMNBzsMLxl4cuSqEhpVrgoksqf2nLfrUw1IZhKS.VcSuOwaoh6vk1IirPasscode: 7YK=s?3=…
Ben Kemp
May 23, 2025
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