Post-marketing surveillance

Post-marketing surveillance refers to the process of monitoring and collecting information on the safety of medicines in everyday practice, after their approval for use in a population. Post-marketing surveillance mostly concerns adverse drug reactions (ADRs) identifying, monitoring and evaluation.  

Monitoring is undertaken by the marketing authorization holders in each country over extensive periods of time as a requisite by regulatory  authorities to maintain the marketing authorization. 

Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics (WHO, 2021)