EMA Undertook 14 RWE Studies In 2018 To Complement Company Data

16 May 2019

Pharmacoepidemiologists and statisticians at the European Medicines Agency used databases of electronic healthcare records to support decision-making by its scientific committees using real-world evidence.

The EMA Has Been Performing Database Studies Since 2013 • Source: Shutterstock

Real-world evidence (RWE) studies are increasingly being undertaken, not just by drug companies but also regulatory authorities, to better understand the benefit-risk profile of medicines. In 2018, the European Medicines Agency used two in-house databases of electronic healthcare records to perform 14 studies to provide RWE to its scientific committees.

These studies were performed by EMA staff – pharmacoepidemiologists and statisticians – to generate evidence in order to complement the...