The International Council on Harmonisation (ICH) announced the adoption of its M14 guideline, which aims to harmonize the planning, design, and reporting of pharmacoepidemiologic studies that use real-world data (RWD) to evaluate the safety of marketed drugs and vaccines. The guideline also provides high-level best practices for conducting these studies.
The guideline reached Step 4 of the ICH process in September 2025 and is now ready for regulatory implementation.
The guidance states that “generation of robust evidence to be used for regulatory purposes depends on the reliability and relevance of the data and the application of sound methods to analyse such data. The use of noninterventional studies for regulatory decision-making has increased globally, and multiple guidelines and best practice documents have been developed by regulators and professional societies.”