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MHRA - launches AI Airlock to address challenges for regulating medical devices that use Artificial Intelligence

9th May 2024

New regulatory sandbox for AI as a Medical Device (AIaMD).

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EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)

8th May 2024

22-25 April 2024

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EMA - One Health: a joint framework for action published by five EU agencies

8th May 2024

The European Centre for Disease Prevention and Control (ECDC), the European Chemicals Agency (ECHA), the European Environment Agency (EEA), the European Food Safety Authority (EFSA), and the European Medicines Agency (EMA) published a joint framework for action to strengthen cooperation to support the implementation of the One Health agenda in the European Union (EU).

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FDA - Roundup

8th May 2024

7th May 2024

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MHRA - April MedTech regulatory reform update: international recognition, IVDs and AI

8th May 2024

Laura Squire, 25 April 2024

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MHRA - Update on pioneering initiative on regulation and evaluation of digital mental health technologies

8th May 2024

An MHRA and NICE partnership, funded by Wellcome, is addressing key challenges for regulating and evaluating digital mental health technologies (DMHTs) with input from patients, the public and mental health professionals.

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EMA - draft reflection paper on the use of real-world data in non-interventional studies to generate real-world evidence

7th May 2024

We are pleased to inform you about the publication of a draft reflection paper on the use of real-world data in non-interventional studies to generate real-world evidence, which is now open for public consultation. The reflection paper discusses methodological and data quality aspects of non-interventional studies using real-world data to generate real-world evidence for regulatory purposes.

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FDA - Data Integrity for In Vivo Bioavailability and Bioequivalence Studies

7th May 2024

Submit Comments by 03/07/2024

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MHRA - sets out its strategic approach to artificial intelligence (AI)

1st May 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has today (30 April 2024) set out its strategic approach to artificial intelligence (AI).

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EDQM - Public consultation on Traceability of Medicines in Hospital Settings

24th April 2024

Share your comments with the EDQM

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