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EMA issues new guidance on conducting clinical trials during public health emergencies in the EU

12th March 2026

The European Medicines Agency has released new guidance to support clinical trials during public health emergencies.

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FDA launches new Adverse Event Look-up Tool

12th March 2026

The US Food and Drug Administration has introduced a new tool to improve access to adverse event data.

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FDA publishes CDER Guidance Agenda outlining planned drug guidance documents

12th March 2026

The US Food and Drug Administration has published its latest CDER Guidance Agenda setting out potential guidance documents for drug regulation.

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MHRA News: £14bn opportunity identified through medicine reclassification

12th March 2026

New analysis highlights the economic and healthcare benefits of expanding access to medicines through reclassification.

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Singapore reaches WHO’s highest classification for medical device regulation

12th March 2026

Singapore has become the first country to achieve the World Health Organization’s highest classification for medical device regulatory systems.

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Global impact of UK health data resource highlighted in newly published paper

11th March 2026

A new paper highlights the worldwide research impact of a major UK health data resource.

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IMDRF launches consultation on clinical evidence for IVD medical devices

11th March 2026

The International Medical Device Regulators Forum has opened a public consultation on new guidance for clinical evidence and performance evaluation of IVD medical devices.

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MHRA publishes guidance on GMP and radiopharmaceutical investigational medicines in clinical trials

11th March 2026

New UK guidance explains manufacturing and regulatory expectations for investigational medicines used in clinical trials.

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Human Medicines Highlights March 2026

6th March 2026

The newsletter for patients, consumers and healthcare professionals

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E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports

5th March 2026

The FDA has published draft guidance based on the ICH E2D(R1) guideline, which updates international standards for managing and reporting post-approval safety data for medicines.

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