OBJECTIVES: To analyse the current requirements and patterns for drug use monitoring in Europe and highlight new ways for pharmaceutical companies to meet these requirements  METHODS: We combined three methods of data collection to characterise current requirements and patterns for drug use monitoring: 1) review of official reports by European agencies; 2) analysis of data elements on the European Medicines Agency (EMA) website; and 3) interviews with experts from pharmaceutical companies, facing requirements for conducting drug utilisation studies (DUS). RESULTS: The recent Good Vigilance Practice (GVP) established a clear regulatory framework for drug safety monitoring and calls for the assessment of the effectiveness of risk minimisation measures (RMMs). This should include the evaluation of their implementation and outcome. DUS provide simple metrics for monitoring of appropriate drug use, and thus the implementation of RMMs. We identified 28 drugs with DUS in their risk management plan and an additional 23 DUS requested by EMA. We observed a top total number of requests for DUS in the fields of contraception (n=10), infectious diseases (mainly HIV and hepatitis) (n=8) and  diseases of the metabolism (mainly diabetes) (n=6) and less for other therapeutic areas. The main reasons for DUS requests were monitoring of off-label use (n=30) and new safety concerns (n=27). Experts confirmed an increasing demand for DUS. In order to optimise the RMMs, repetitive DUS in different points in time are necessary. This study analyses DUS’ critical data elements allowing for the automation of such measurements. CONCLUSIONS: Current and future EMA practice for DUS seems to focus on new active substances, particularly in diseases of high public health relevance and infectious diseases. To meet this demand, pharmaceutical companies are required to propose more repetitive measurements of the drug use. This study identifies data elements allowing for the automation of such measurements.