Consultation on the International Council for Harmonisation (ICH) M14
Published 29 August 2024
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Consultation Details
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
The MHRA is an executive agency of the Department of Health and Social Care.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) brings regulatory authorities and the pharmaceutical industry together with a mission to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner. Harmonisation is achieved through the development of ICH Guidelines.
The ICH Expert Working Group (EWG) for M14 has been updating the guideline on General principles on plan, design, and analysis of pharmacoepidemiological studies that utilise real-world data for safety assessment of medicines.
The guideline will focus on non-interventional pharmacoepidemiological studies using Real-World Data (RWD) and will include basic principles that may apply to these studies when real-world data elements are included. See the draft M14 guidelines.
We invite UK stakeholders and other ICH members to complete the consultation. Following the consultation, the feedback will be reviewed and discussed by the ICH M14 EWG.
We do not intend to publish a full response to this consultation.