News Archive

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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MHRA - MHRA Publishes Standardised Format for Medical Device Post-Market Surveillance Reports

9th September 2025

The MHRA has released a standardised template to improve post-market surveillance of medical devices.

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MHRA Seeks Input on Prioritisation of Designated Standards

9th September 2025

The MHRA is consulting stakeholders on how to prioritise standards for medical devices.

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FDA - Annual report on the State of Pharmaceutical Quality

3rd September 2025

The annual report on the State of Pharmaceutical Quality is intended to help characterise the quality of the U.S. drug supply chain. Released 2nd Sept 2025.

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MHRA - August MHRA News

3rd September 2025

The essential industry newsletter where we update you on our most recent activities.

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