Final ICH M14 Guideline on the Use of RWD for Safety Assessment

The ICH M14 guideline on “General Principles on Planning, Designing, Analysing, and Reporting of Non-interventional Studies That Utilise Real-World Data for Safety Assessment of Medicines” has reached Step 4 of the ICH (International Council for Harmonisation) process and has now entered the implementation phase. The guideline provides the first internationally harmonised recommendations for non-interventional pharmacoepidemiological studies that generate real-world evidence (RWE) for post-marketing safety submissions. It acknowledges regional differences in RWD definitions and allows supplementary data, including primary data collection, where appropriate. These recommendations aim to minimize the need for multiple studies on the same safety concern for regulatory submissions, improve regulatory acceptance of protocols across regions, and ultimately support regulatory decision-making.  

The European Medicines Agency (EMA) has now published the guideline, which will be applied within the European legal framework starting on 18 March 2026. The EMA states that the guideline's key principles may also apply to effectiveness studies.

Further information can be found on the ICH M14 page and on the EMA website.