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MHRA and US FDA Forge New Collaboration on Medical Technologies and AI

10th October 2025

The UK and US regulators have strengthened their partnership to accelerate innovation, enhance patient safety, and reduce market access barriers for medical technologies and AI-driven healthcare solutions.

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UK Clinical Trial Approval Times Halved with AI and Regulatory Reforms

10th October 2025

The UK has reduced clinical trial approval times from 91 to 41 days, enhancing patient access to new treatments.

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WHO Launches Global Clinical Trials Forum to Strengthen Research Infrastructure

10th October 2025

On 7th October 2025, the World Health Organization (WHO) officially launched the Global Clinical Trials Forum (GCTF), a collaborative network aimed at enhancing clinical trial environments and infrastructure globally.

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New Commission to Accelerate NHS Use of AI

26th September 2025

The UK establishes a National Commission to expedite safe AI integration into the NHS.

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FDA Issues Final Guidance on Computer Software Assurance for Production and Quality System Software

25th September 2025

The FDA has released final guidance to streamline software assurance in medical device manufacturing.

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GVP Regulatory News 2025

22nd September 2025

Now Available

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MHRA - Looking to Our Future: Reflections on Strategic Choices Ahead for the MHRA

17th September 2025

The MHRA reflects on its future priorities to strengthen healthcare regulation and innovation.

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MHRA - New Regulations for Clinical Trials: Join Our Route B Substantial Modifications Pilot

17th September 2025

The MHRA launches a pilot to test streamlined processes for substantial modifications in clinical trials.

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MHRA and Department for Education Embed Medicine Safety into School Curriculum

17th September 2025

The MHRA is working with schools to teach young people about safe medicine use.

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MHRA Blog: Decentralised Manufacturing: Emerging Considerations

15th September 2025

The MHRA explores the growing role of decentralised manufacturing in pharmaceuticals and its regulatory implications.

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