Electronic healthcare databases (EHDs) are useful tools for drug development and safety evaluation but their heterogeneity of structure, validity and access across
Europe complicates the conduct of multidatabase studies. This paper provides insight into available EHDs to support regulatory decisions on medicines.
A Few European databases meet minimal regulatory requirements and are readily available to be used in a regulatory context. Accessibility and validity information of the included information needs to be improved. This study confirmed the fragmentation, heterogeneity and lack of transparency existing in many European EHDs.
Pacurariu A, Plueschke K, McGettigan P, et al. Electronic healthcare databases in Europe: descriptive analysis of characteristics and potential for use in medicines regulation. BMJ Open 2018;8:e023090. doi: 10.1136/bmjopen-2018-023090