Points to consider for engagement of regulators, patients and healthcare professionals are under development at the European Medicines Agency (EMA) in order to ensure systematic, consistent and effective engagement for real-world input to risk assessments, evaluation of risk minimisation measures and decision making.

The analysis of six cases of major safety concerns for which different engagement mechanisms were used by EMA for the first time shows that the framework of the International Risk Governance Council (IRGC) appears applicable to pharmacovigilance activities.

A decision guide that brings together the IRGC recommendations and the regulatory risk assessment process, to support selecting discourse types and engagement mechanisms in given risk scenarios, is proposed for piloting at EMA and refinement as a tool for regulators.