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Ben Kemp

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

DBT Updates (WC 6 Jan)

The UK and the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) Page summary: Business guidance, treaty information and other documents to help you understand the UK’s accession to the CPTPP. Change made: Amended page to reflect ratification of UK’s membership of CPTPP. Time updated: 12:00am, 24 December 2024   UK trade agreements in effect Page summary: Find out about trade agreements…
Ben Kemp
January 8, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

UKHSA Updates (WC 6 Jan)

Marburg virus disease: origins, reservoirs, transmission and guidelines Page summary: Marburg virus is a filovirus which, along with Ebola virus, can cause a severe and often fatal viral haemorrhagic fever (VHF). Change made: Updated the epidemiology section and map. Time updated: 10:24am, 30 December 2024 Notifiable diseases: causative agents reports for 2024 Page summary: Weekly data from UK laboratories on…
Ben Kemp
January 8, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Updates (WC 6 Jan)

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 spreadsheet Time updated: 1:52pm, 23 December 2024 Orphan registered medicinal products Page summary: A list of authorised orphan medicinal products registered by the UK licensing authority. Change made: Removed…
Ben Kemp
January 8, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Share your views: Consultation on proposed amendments to regulations to address health product shortages in Canada

Current status: Open Opened on December 28, 2024 and will close on March 8, 2025. Health Canada is proposing to amend the Food and Drug Regulations and Medical Devices Regulations to help prevent and mitigate the risk of harm to human health due to drug and medical device shortages and discontinuations. The proposed amendments: are outlined in the Regulations Amending…
Ben Kemp
January 8, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Update from GOV.UK for: Radio equipment regulations

Radio equipment regulations Page summary: Guidance for businesses on the Radio Equipment Regulations 2017 and Radio Equipment (Amendment) (Northern Ireland) Regulations 2024. Change made: New guide added on the Radio Equipment (Amendment) (Northern Ireland) Regulations 2024, and existing guides revised following legislation to extend recognition of CE marking on products being placed on the Great Britain market which came into…
Ben Kemp
January 8, 2025
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

IVDR/MDR implementation – EU Commission (GÖG) Survey – Please participate (Deadline 28/02/2025)

The European Commission continues to gather evidence of the impact of IVDR implementation, especially on manufactures plans to transition devices from IVD directive to IVD Regulation, or more importantly which devices manufacturers do not intend to transition. UK manufactures or subsidiaries who place product on the EU market including Northern Ireland are strongly encouraged to respond, noting that group companies…
Ben Kemp
January 8, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

HRA Review of 2024

Welcome to the final edition of HRA Latest for 2024. As we round off the year our Chief Executive, Matt Westmore, has written a blog reflecting on how the Health Research Authority has supported research in the UK throughout 2024. In the blog Matt also looks ahead to our new strategy and what our priorities will be in 2025. Read…
Ben Kemp
January 8, 2025
HighlightsHighlights ArchiveSustainability Programme Archive

Media Monitoring: 1st – 8th January

New saliva test can rapidly identify paracetamol overdose A research team led by the University of Liverpool has developed an innovative new technique that can rapidly assess paracetamol levels from saliva. The team demonstrates the clinical validity of a new mass spectrometry technology-based technique that can test a tiny drop of saliva on a piece of paper for levels of…
Ben Kemp
January 8, 2025
ConsultationsConsultations ArchiveMembership NewsMembership News Archive

Comments requested on UK SMI B 10: Investigation of faecal specimens for Clostridioides difficile

UKHSA requests your comments on the following document: UK SMI B 10: Investigation of faecal specimens for Clostridioidies difficile To take part in the consultation please go to the relevant page by clicking on the link below and navigate to the 'Open Consultation' accordion. Please send comments by 17th January 2025 using the consultation form provided on the website. The relevant…
Ben Kemp
January 7, 2025
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