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HRA - Shaping the future of UK life sciences

3rd February 2025

Blog post - how regulators can support growth which helps everyone

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MHRA - Current approaches to product marking

3rd February 2025

New guidance on product marking, including the continued recognition of certain EU requirements, such as CE marking, for specific product sectors.

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EMA - CTIS Newsflash 28th Jan 2025

30th January 2025

New issue released.

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EMA - European Shortages Monitoring Platform Operational

30th January 2025

European Shortages Monitoring Platform fully operational for monitoring of shortages in the EU

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MHRA - Drug Safety Update Jan 2025

30th January 2025

Out now.

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MHRA - Graduate Scheme

30th January 2025

Detailed released.

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MHRA - Innovative Licensing and Access Pathway (ILAP)

30th January 2025

Full details have been published today of the refreshed UK-wide Innovative Licensing and Access Pathway (ILAP), that will offer a clearer, more streamlined and integrated process for developers to help get transformative new medicines to patients in the National Health Service (NHS) in the shortest time possible.

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ICH - E6(R3) Training Available

27th January 2025

The ICH E6(R3) Introductory Training Presentation is now available on the ICH website

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ICH - ICH E6(R3) - Step 5

27th January 2025

ICH E6(R3) (Principles and Annex 1), has reached Step 5 and will be effective from June 2025, and adopted on the 23rd July. ICH E6 (R2) remains in effect until 11 June 2025.

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EMA - CVMP Meeting highlights 14-15 Jan 2025

21st January 2025

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 14-15 January 2025

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