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CTIS Newsletter - April 2026

30th April 2026

Updates on the ACT EU initiative, CTIS and the clinical trials landscape in the EU

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MHRA Safety Roundup: April 2026

30th April 2026

Latest updates on medicine and medical device safety from the MHRA.

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MHRA hires top global tech talent to modernise regulatory systems

30th April 2026

New digital expertise aims to strengthen how medicines and devices are regulated in the UK.

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Diagnostic radiopharmaceutical IMPs and GMP requirements

28th April 2026

Guidance clarifies GMP expectations for diagnostic radiopharmaceuticals used in clinical trials.

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ICH E6 Good Clinical Practice guidance now in force in the UK

28th April 2026

Updated GCP guidance aligned with ICH E6 is now officially in force for UK clinical trials.

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Launch of clinical trial reforms

28th April 2026

UK government announces major reforms to improve the speed and efficiency of clinical trials.

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Notification of serious breaches of GCP or the trial protocol

28th April 2026

Guidance outlines how and when to report serious breaches in clinical trials.

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Route B substantial modifications pilot: the results are in

27th April 2026

MHRA shares findings from its pilot to improve how substantial clinical trial modifications are handled.

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OpenAI launches GPT-Rosalind for life sciences workflows

21st April 2026

A new OpenAI model aims to speed up biology and drug development research while keeping scientists firmly in control.

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National AI Commission: Ask Me Anything

20th April 2026

Insights from the National AI Commission addressing key questions on AI’s future in the UK.

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