In these newly published FAQs, Swissmedic addresses frequently asked questions on drug safety signals, Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs) and related information materials, and Direct Healthcare Professional Communications (DHPCs).
The answers are designed to help marketing authorisation holders and other stakeholders acquire a practical understanding of the requirements, procedures, and expectations relating to risk management.
If you have any questions about risk management that are not addressed in these information sources or in other published forms and guidance documents, please contact riskmanagement@swissmedic.ch.
The FAQ document is valid with effect from 1 April 2026.