ICH adopts new guideline on real-world data studies for medicine safety assessment
The International Council for Harmonisation (ICH) has adopted its M14 guideline. The ICH M14 guideline establishes internationally harmonised principles for the planning, design, analysis and reporting of non-interventional pharmacoepidemiological studies that use real-world data (RWD) to assess the safety of medicines. It aims to improve the reliability and regulatory acceptance of such studies by providing a structured framework that includes feasibility assessments, protocol development, data management and statistical analysis. The guideline emphasises the importance of fit-for-use data, robust study design and early engagement with regulators to ensure that evidence generated is adequate for post-marketing safety evaluations. It also outlines considerations for bias, confounding and validation of key variables and encourages transparency through public registration and dissemination of study findings.