Skip to main content
search
Category

Regulatory Affairs Newsletter Archive

UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

UK HSA weekly update (WC 18 Dec)

Please note this is an extract of the original bulletin. Committees on Toxicity, Mutagenicity, Carcinogenicity of Chemicals in Food, Consumer Products and the Environment: joint annual report Page summary: Joint annual report includes brief toxicological background to the Committees’ decisions; discussion summaries; Committees’ published statements. Change made: Added 2022 joint annual report.
admin
January 3, 2024
FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter Archive

FDA publishes a new draft guidance on 510(k) Third Party Review Program

The US FDA have published 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations This draft guidance outlines FDA's current thinking on key aspects of the 510(k) Third Party Review Program and third party review of Emergency Use Authorization (EUA) requests by…
admin
January 3, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 18 Dec)

Please note this is an extract of the original bulletin. International Recognition Procedure* Page summary: How to use this new procedure for medicines licensing applications. Change made: Added recording of ‘MHRA International Recognition Webinar November 2023’. *Please note this update does not include medical and IVD devices. Notify the MHRA about a clinical investigation for a medical device Page summary:…
admin
January 3, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

New MHRA monthly newsletter

The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components for transfusion in the UK. Subscribe to their new monthly newsletter to stay informed on what is going on at the MHRA. MHRA Newsletter December 2023 Please note this is an extract of the original bulletin. Clinical Trials and Investigations Performance The latest MHRA performance data shows…
admin
January 3, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 18 Dec)

Please note this is an extract of the original bulletin. Joint outcome statement: UK-India round thirteen of FTA negotiations Page summary: Round thirteen of negotiations for a free trade agreement between the United Kingdom and the Republic of India Change made: First published. First UK Trade Mission to Kyiv Boosts Defence Cooperation Page summary: UK Government and UK defence industry…
admin
January 3, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 18 Dec)

Please note this is an extract of the original bulletin. The Data Protection (Fundamental Rights and Freedoms) (Amendment) Regulations 2023 Page summary: The Statutory Instrument (SI) will amend references to ‘fundamental rights and freedoms’ in the UK’s data protection legislation. Change made: Made: 18 December 2023 replaced Laid before Parliament: 7 November 2023. UK-Japan science and innovation funding opportunities Page…
admin
January 3, 2024
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter Archive

New available International Standards on Artificial Intelligence

CEN and CENELEC identifies and adopts two international standards on Artificial Intelligence: ISO/IEC/TR 24027:2023 - Information technology - Artificial intelligence (AI) - Bias in AI systems and AI aided decision making and ISO/IEC TR 24029-1:2021 - Artificial Intelligence (AI) - Assessment of the robustness of neural networks - Part 1: Overview. These standards are available from 20 December.
admin
January 3, 2024
Close Menu