EMA publishes updated reflection paper on RWD use in non-interventional studies

The European Medicines Agency has published a revised reflection paper setting out updated guidance on the use of real-world data in non-interventional studies submitted for regulatory purposes. The document addresses longstanding concerns around data quality, fitness-for-purpose assessments, and the transparency of analytical decisions, reflecting the Agency’s growing experience with post-authorisation evidence generation. Notably, the revised paper places greater emphasis on study pre-specification, data provenance, and the documentation of methodological choices — areas where regulatory scrutiny has visibly intensified in recent years. The guidance applies across a range of regulatory contexts, including post-authorisation safety and effectiveness studies. For RWE, HEOR, and regulatory affairs teams, this update warrants a careful review of existing non-interventional study protocols and data governance frameworks to ensure alignment with current EMA expectations ahead of any regulatory dialogue.