European Medicines Agency (EMA) | What's new Follow 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 Step 5 https://www.ema.europa.eu/system/files/documents/scientific-guideline/ich-m14-guideline_step-5_en.pdf ema.europa.eu
