Stakeholders in Switzerland have the possibility to comment on the draft of Guideline M14 “General principles on plan, design, and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines” until 30 August 2024.
While the number of pharmacoepidemiological studies utilising real-world data (RWD) in a regulatory context have increased globally, there are currently no ICH guidelines that focus on how to generate fit-for-purpose real-world evidence (RWE). Although many regions have published guidelines relating to general principles of planning and designing such studies, mainly for the purpose of drug, vaccine and other biologic safety assessments, a lack of harmonisation in this area can cause challenges for sponsors and regulators. The proposed guideline will outline general considerations and recommendations for the use of RWD for drug, vaccine and other biologic product safety assessments, including defining the research question, data source selection/generation, study design, definitions of target populations, exposure and outcome(s), covariates, data source fit-for-purpose evaluation, sources of and methods to address confounding and bias, analytic approaches, and format and content of reporting.
Comments can be sent using the feedback form specified by ICH to networking@swissmedic.ch. Stakeholders will receive confirmation of receipt of their comments but no feedback on the individual comments. After completion of the public consultation phase, the comments submitted will be discussed in the responsible ICH working group and taken into account where appropriate.
Links to the guideline and feedback form can be found on the following page:
International Council for Harmonisation (ICH) (swissmedic.ch)