News Archive

MHRA - Regulatory Roadmap points the way ahead for new measures to support safe access to medical technology including AI and diagnostics

9th January 2024

MHRA sets out new plans to protect patient safety and enable access without delay for UK patients to innovative medical technologies.

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EMA/FDA - Joint Q&A on quality development and good manufacturing practice for Priority Medicines (PRIME) and Breakthrough therapy (BT) designation applications

20th December 2023

This Q&A provides medicine developers with guidance on how to address challenges associated with expedited product development, so that robust quality and manufacturing data packages will be available to support their application.

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EMA - Final version of HMA-EMA Big Data Steering Group's Multi-annual Artificial Intelligence Workplan 2023-2028

19th December 2023

EMA are pleased to inform you that the final version of the HMA-EMA Big Data Steering Group's Multi-annual Artificial Intelligence Workplan 2023-2028 has been published.

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EMA - CTIS newsflash – 8 December 2023

15th December 2023

This regular CTIS newsflash provides key updates on CTIS and links to useful reference materials.

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EMA - Human Medicines Newsletter 175

15th December 2023

Nov-Dec 23

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MHRA: GMP & GDP Certificates

15th December 2023

Validity Period Extended

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MHRA: MHRA supports launch of Innovate UK’s first-of-its-kind initiative to fund new Regulatory Science and Innovation Networks

15th December 2023

Applications are now open for academic institutions wishing to bid for funding to collaborate with others to establish new Regulatory Science and Innovation Networks (RSINs) in innovative sectors.

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EMA - Data Quality Framework for EU medicines regulation

14th December 2023

EMA releases first version of their Data Quality Framework for EU Medicines Regulation.

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EMA - EU medicines agencies reflect on lessons learned from COVID-19

6th December 2023

A joint report issued by the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) reviews the Network’s response and highlights the main learnings for any future health crises.

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EMA - Implementation strategy for ICH M10

6th December 2023

The EMA has issued their implementation strategy for ICH M10 – public consultation is open until until 31 January 2024.

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