The AU-3S programme is a smart fit-for purpose continental safety surveillance system (encompassing both passive and active surveillance approaches) for priority products that will support African Union Member States, at the continental level, to safeguard the health of their citizens. The system covers the entire product life cycle from clinical trials through product approval to post-approval monitoring for safety and effectiveness. The AU-3S programme will be implemented under three major priority areas, namely: an appropriate governance model; fit-for-purpose technologies; and adequate resourcing to ensure consistent normative standards drive the assessment, decision making and other pertinent aspects of the process.