News Archive

EMA - IRIS Documentation

15th January 2025

Released January 2025

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FDA - Advanced Manufacturing Technologies Designation Program

15th January 2025

Final guidance released

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FDA - Roundup, 14th January 2025

15th January 2025

An at-a-glance summary of news from around the agency

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MHRA - Good Clinical and Laboratory Practice Symposia

15th January 2025

11th and 12th February 2025

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MHRA - ICH M15 Model Informed Drug Development (MIDD) Guideline

15th January 2025

Blog post by Essam Kerwash The International Council for Harmonisation (ICH) M15 Model informed Drug development (MIDD) Guideline has reached Step 2b and is available for public consultation. As a clinical pharmacology assessor at the UK Medicines and Healthcare products Regulatory Agency (MHRA), I was involved with the development of this guidance.

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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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