ICH M14 guideline open for consultation

The use of pharmacoepidemiological studies as a source of real-world evidence (RWE) for regulatory decision-making has increased globally, and multiple guidelines and best practice documents have been, and will be, developed by health authorities and professional societies, including the recent EMA Draft RWE reflection paper on use of real-world data (RWD) in non-interventional studies (NIS).

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

To ensure that all concerned European stakeholders are given the opportunity to comment, EMA is coordinating a European public consultation until 31 August 2024, in parallel to the global public consultation launched by ICH.

ENCePP Partners are invited to submit their comments on the draft guideline to ICHema [dot] europa [dot] eu (ICH[at]ema[dot]europa[dot]eu) until 31 August 2024, using this Template.