Open consultation

Consultation on the International Council for Harmonisation (ICH) M14

• From: Medicines and Healthcare products Regulatory Agency
• Published: 29 August 2024

Summary

Consultation on the ICH E2D(R1) guidelines on General principles on plan, design, and analysis of pharmacoepidemiological studies that utilise real-world data for safety assessment of medicines.

This consultation closes at
11:59pm on 30 October 2024

Consultation description

The Medicines and Healthcare products Regulatory Agency (MHRA) became a full member of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in May 2022 and is consulting with UK stakeholders and ICH members on the ICH E2D(R1) guideline on General principles on plan, design, and analysis of pharmacoepidemiological studies that utilise real-world data for safety assessment of medicines.

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Consultation on the International Council for Harmonisation (ICH) M14

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Published 29 August 2024