Several countries in the European Union (EU) and European Economic Area (EEA) established and/or scaled up HIV pre-exposure prophylaxis (PrEP) programmes between 2016 and 2023. Data on PrEP programmes’performance and effectiveness in reaching those most in need will be needed to assess regional progress in the roll-out of PrEP. 
; However, there is a lack of commonly defined indicators for routine monitoring to allow for minimum comparability. We propose a harmonised PrEP monitoring approach for the 
; EU/EEA, based on a systematic and evidence-informed consensus-building process involving a broad and multidisciplinary expert panel. We present a set of indicators, structured along relevant steps of an adapted PrEP care continuum, and offer a prioritisation based on the degree of consensus among the expert panel. We distinguish
; between ‘core’ indicators deemed essential for any PrEP programme in the EU/EEA, vs ‘supplementary’ and ‘optional’ indicators that provide meaningful data, yet where experts evaluated their feasibility for data collection and reporting as very context-dependent. By combining a standardised approach with strategic opportunities for adaptation and complementary research, this monitoring framework will contribute to assess the impact of PrEP on the HIV epidemic in Europe.