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FDA publishes a new draft guidance on 510(k) Third Party Review Program

The US FDA have published 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations This draft guidance outlines FDA's current thinking on key aspects of the 510(k) Third Party Review Program and third party review of Emergency Use Authorization (EUA) requests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…

adminJanuary 3, 2024

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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:…

adminJanuary 3, 2024

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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…

adminJanuary 3, 2024

UK Government Updates Environmental Newsletter UK Government Updates Environmental Newsletter Archive UK Government Updates Regulatory Affairs Newsletter UK Government Updates Regulatory Affairs Newsletter Archive

HMRC weekly update (WC 18 Dec)

Please note this is an extract of the original bulletin. 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: Added information on circumstances where exports do not need a standalone exit summary declaration. Search the register of customs agents and fast…

adminJanuary 3, 2024

APHA weekly update (WC 18 Dec)

Please note this is an extract of the original bulletin. Export blood and blood products for technical use to India: certificate 7204 updated Page summary: Apply online to export blood and blood products for technical use to India. Change made: Guidance notes updated. Check import risk categories and related rules for animals and animal products imported from the EU to…

adminJanuary 3, 2024

UK Government Updates Regulatory Affairs Newsletter UK 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…

adminJanuary 3, 2024

UK Government Updates Regulatory Affairs Newsletter UK 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…

adminJanuary 3, 2024

DEFRA weekly update (WC 18 Dec)

Please note this is an extract of the original bulletin. Government reforms set to spark greater reuse and recycling of electrical goods Page summary: Government will make it easier for people and businesses to reuse and recycle their old electrical goods Change made: First published. Electrical waste: reforming the producer responsibility system Page summary: Seeking views on reforms to increase…

adminJanuary 3, 2024

UK Government Updates Environmental Newsletter UK Government Updates Environmental Newsletter Archive

The Importation of Animals and Related Products (Miscellaneous Amendment and Revocation) (Scotland) Order 2023

The Importation of Animals and Related Products (Miscellaneous Amendment and Revocation) (Scotland) Order 2023 came into force on 01 January 2024. This Order amends or revokes several orders made or having effect under the Animal Health Act 1981 which prohibit the importation of animals and related products, except under the authority of a licence.

adminJanuary 3, 2024

UK Government Updates Environmental Newsletter UK Government Updates Environmental Newsletter Archive

The Producer Responsibility Obligations (Packaging Waste) (Amendment No.2) Regulations (Northern Ireland) 2023

The Producer Responsibility Obligations (Packaging Waste) (Amendment No.2) Regulations (Northern Ireland) 2023 will enter into force on 01 February 2024. These Regulations amend the Producer Responsibility Obligations (Packaging Waste) Regulations (Northern Ireland) 2007 (S.I. 2007 No. 198) (the “2007 Regulations”). Those Regulations impose on producers obligations to recycle packaging waste in order to attain overall recycling and material-specific recycling targets.

adminJanuary 3, 2024