News Archive

MHRA - MHRA guidance on new Medical Devices Post-Market Surveillance requirements

15th January 2025

A suite of guidance has been published by the Medicines and Healthcare products Regulatory Agency (MHRA).

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EMA - CTIS Newsflash - 14th January 2025

14th January 2025

Out now!

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ICH - ICH E6 (R3) - Step 4

14th January 2025

The ICH E6(R3) Guideline reached Step 4 of the ICH process on 6 January 2025.

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MHRA - Patient Involvement Strategy: an assessment of progress

14th January 2025

The Medicines and Healthcare products Regulatory Agency (MHRA) published its first Patient Involvement Strategy in October 2021, covering the period to 2025.

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MHRA - Real-World Evidence Scientific Dialogue Programme

14th January 2025

A programme to help facilitate robust decision-making across the entire lifecycle of products, benefitting both regulatory and Health Technology Assessment (HTA) evaluations relevant to the UK.

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FDA - Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products

8th January 2025

Open for Consultation

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PIC/S - Two guidance documents for inspectors on remote assessments

8th January 2025

"Guidance on Remote Assessments" (PI 056-1) and "Aide Memoire on Remote Assessments" (PI 057-1). These documents have been prepared by the PIC/S Working Group on Remote Assessment.

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