Signals from the Dutch national spontaneous reporting system: Characteristics and regulatory actions

Purpose The aim of the study is to characterise safety signals based on Dutch spontaneous reporting system (SRS) and investigate association between signal characteristics Product Information (PI) update stratified by approval type: centrally authorised products (CAPs) versus nationally decentralised (NAPs). Methods This evaluates full cohort disseminated from SRS in period 2008 2017. Each retrieved was characterised a number aspects. management process generation potential PI analysed four steps: (1) characterisation; (2) proposed actions national competent authority (NCA) for signals; (3) presence (yes/no) with characteristics; (4) timing moment issued update. For step 1–3 we CAPs NAPs. Results Of all signals, 88.7% led regulatory action NCA. Signals NAPs more often concerned biologicals, important medical events, class effects shorter periods since marketing authorization. We detected updates 26.2% CAP 61.3% NAP signals. Conclusions SRSs remains an source There are some notable differences frequently updates.