The PROTECT project on pharmacovigilance achieves key objectives

The PROTECT project, a public-private partnership for innovative methodologies in pharmacovigilance and pharmacoepidemiology, coordinated by the European Medicines Agency (EMA), reached a crucial stage in February 2013, with the delivery of two databases which will offer access to important data resources for pharmacovigilance activities and pharmacoepidemiological studies.

The first of these two databases, the Drug Consumption Database, is a comprehensive and structured source of information on drug consumption in Europe.

The second database, the PROTECT ADR database, is a listing of all ADRs contained in the section 4.8 of the summary of product characteristics (SmPC) of medicinal products centrally authorised in the EU.