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Regulatory Affairs Newsletter Archive

The first six EU reference laboratories for public health are now operational European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

The first six EU reference laboratories for public health are now operational

The first six EU reference laboratories for public health are now operational Since 1 January 2025, the first six EU reference laboratories (EURLs) for public health have been operational and will now carry out activities for the next seven years. The EURLs, which bring together consortia of scientific expertise from across the EU, contribute to improving EU preparedness and ensuring…
Ben Kemp
January 9, 2025
Health Technology Assessment – Commission adopts rules for joint scientific consultations on medicinal products for human use European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Health Technology Assessment – Commission adopts rules for joint scientific consultations on medicinal products for human use

Health Technology Assessment - Commission adopts rules for joint scientific consultations on medicinal products for human use Recently, the European Commission adopted an implementing regulation setting out the rules for joint scientific consultations on medicinal products for human use at Union level, under the Health Technology Assessment (HTA) Regulation. The implementing act provides detailed procedural rules for the joint scientific…
Ben Kemp
January 9, 2025
Copyright and Artificial Intelligence Consultation Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Copyright and Artificial Intelligence Consultation

This consultation seeks views on how the government can ensure the UK’s legal framework for AI and copyright supports the UK creative industries and AI sector together. This consultation closes at 11:59pm on 25 February 2025 Access it here.
Ben Kemp
January 9, 2025
The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024

As promised by the MHRA, the Post Market Survailence Statutory Instrument 2024 No. 1368  modifying the UK MDR 2002 (as amended), has been published 16th December 2024, and there for applies for all IVD’s placed on the GB market from 16th June 2025. If you’ve not already started preparing your Quality Management systems for the update, now the time to…
Ben Kemp
January 8, 2025
DSIT Updates (WC 6 Jan) Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT Updates (WC 6 Jan)

UK Science and Innovation Network impact stories Page summary: These impact stories highlight the work of the UK Science and Innovation Network (SIN) around the world. Change made: Added SIN impact story covering support for semiconductors in Japan. Time updated: 9:44am, 16 December 2024 Public attitudes to data and AI: Tracker survey (Wave 4) Page summary: Report detailing the findings…
Ben Kemp
January 8, 2025
Brexit: Safety and security requirements on imports and exports Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Brexit: Safety and security requirements on imports and exports

Safety and security requirements on imports and exports Page summary: Find out about safety and security requirements that apply to goods entering and exiting the UK. Change made: Information about qualifying and non-qualifying goods arriving in Great Britain (England, Scotland and Wales) has been updated. Time updated: 2:00pm, 16 December 2024
Ben Kemp
January 8, 2025
DBT Updates (WC 6 Jan) 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
UKHSA Updates (WC 6 Jan) 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