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Registration is now open for the Clinical Trials (CTs) with in vitro Diagnostic (IVD) devices webinar

Dear Colleagues, We are delighted to invite you to the Clinical Trials (CTs) with in vitro Diagnostic (IVD) devices webinar on Tuesday, 3 February 2026 from 14:00-15:00 (GMT). During this webinar the MHRA will present guidance and advice to sponsors who are submitting clinical trials with in vitro Diagnostic (IVD) devices. The webinar will be presented in sections including: Clinical Trials with IVDs The…
Ben Kemp
January 15, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Biocides: Upcoming EU active substance expiry dates postponed, approval dates and dossier submission deadline

Upcoming EU active substance approval dates Apply for product authorisation by the deadlines to keep your products on the NI market. The following EU BPR active substance approval dates are coming up: 1 March 2026 silver zinc zeolite (CAS 130328-20-0 EC 603-404-0) in product types 2, 7 and 9 If you supply biocidal products containing these active substances in the…
Ben Kemp
January 15, 2026
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TGA Australia – Proposed amendments relating to transparency of disruptions to supply of medical devices

Dear members, please let me know via regulatory@bivda.org.uk any feedback to the TGA Australia - Proposed amendments relating to transparency of disruptions to supply of medical devices. Consultation closes 20th Feb 2026.   TGA want your feedback on the proposed changes to improve transparency about disruptions to the supply of medical devices.   Consultation: Improved sharing of information about medical…
Ben Kemp
January 15, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Guidance on Good Clinical Practice (GCP) available

New regulations for clinical trials go live on 28 April 2026: Be ready New – Good Clinical Practice guidance (GCP) 28 April 2026 is the implementation date for the new regulations for clinical trials, and we’ve just added some guidance about Good Clinical Practice (GCP) to our Clinical Trials hub (CT hub).  New draft guidance is about:  Declaration of Helsinki and Clinical Trials Regulations alignment  Archiving…
Ben Kemp
January 15, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Updates – WC 12th January

MHRA welcomes Professor Jacob George as he starts Chief Medical and Scientific Officer role Page summary: In this new role, Professor George will lead the Agency’s science strategy and will oversee the MHRA’s scientific, research and innovation activities. Change made: First published. Time updated: 11:24am, 5 January 2026 Medical devices given exceptional use authorisations Page summary: List of manufacturers and…
Ben Kemp
January 15, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Brexit Updates – WC 12th January

Check if you can claim a waiver for goods brought into Northern Ireland Page summary: You may be able to claim a waiver for goods brought into Northern Ireland so that you do not have to pay duty on those goods. Change made: The date when you must update the sector of your undertaking in the digital service has now…
Ben Kemp
January 15, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Science, Innovation and Technology Update – WC 12th January

New cyber action plan to tackle threats and strengthen public services Page summary: New measures will be introduced to make online public services more secure and resilient, so people can use them with confidence – whether applying for benefits, paying taxes or accessing healthcare. Change made: First published. Time updated: 12:01am, 6 January 2026 AI Exemplars programme Page summary: AI…
Ben Kemp
January 15, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department of Health and Social Care Update – WC 12th January

Edwards’ syndrome screening: equality impact assessment Page summary: Equality impact assessment on screening for Edwards’ syndrome using the antenatal quadruple test in the NHS Fetal Anomaly Screening Programme (FASP). Change made: First published. Time updated: 2:00pm, 5 January 2026 Screening programme impact assessments Page summary: Impact assessments (IAs) and equality impact assessments (EIAs) for new and amended NHS screening programmes.…
Ben Kemp
January 15, 2026
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