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Regulatory Affairs Newsletter Archive

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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
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
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
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
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
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