ICH M14 guideline on general principles on plan, design and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines - Scientific guideline

This guideline provides internationally harmonised guidance and outlines recommendations and high-level best practices for the conduct and analysis of non-interventional pharmacoepidemiological studies using fit-for-purpose data for the assessment of the safety of medicines (drugs, vaccines, and other biological products). It aims to streamline the development and regulatory assessment of study protocols and reports, and improve their ability to be accepted across health authorities.

The use of pharmacoepidemiological studies as a source of evidence for regulatory decision-making has increased globally, and multiple guidelines and best practice documents have been developed by health authorities and professional societies. Generation of robust evidence to be used for regulatory purposes relies on the quality of the data and the application of sound pharmacoepidemiological methods. 

Keywords: real-world data (RWD), pharmacoepidemiology, non-interventional studies, safety, post-authorisation

Current version

ICH M14 guideline on general principles on plan, design and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines Step 2b

Draft: consultation closedConsultation dates: 30/05/2024 to 30/08/2024Reference Number: EMA/CHMP/ICH/155061/2024Summary:

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Overview of comments received on ICH M14 Guideline on general principles on plan, design and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines

Reference Number: EMA/417650/2024