News Archive

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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EMA - COVID-19 vaccine strain updates

24th April 2024

Global regulators agree on timing and data requirements

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EMA - Human Medicines Newsletter 379

24th April 2024

April 2024

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EMA - Meeting highlights from the CVMP

24th April 2024

16-18 April 2024

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EMA - New recommendations to strengthen supply chains of critical medicines

24th April 2024

EMA has published a number of recommendations to address vulnerabilities in the production and delivery of medicines included in the Union list of critical medicines and strengthen their supply chain.

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FDA - Data Standards Catalog - Open for Comments

24th April 2024

Released April 2024

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FDA Roundup - 23rd April 2024

24th April 2024

An at-a-glance summary of news from around the agency.

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