Regulatory Focus™ > News Articles > Two New Pharmacovigilance Databases Launched in EU

Two New Pharmacovigilance Databases Launched in EU

Posted 13 February 2013 | By

The Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT) has achieved the goal of creating two new databases for pharmacovigilance and pharmacoepidemiological studies in Europe.

The first, the Drug Consumption Database, draws on out- and in-patient healthcare information from 17 EU countries: Belgium, Bulgaria, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Latvia, Norway, Poland, Portugal, Spain, Sweden, The Netherlands, and the UK.

The second, the PROTECT ADR database, lists all of the adverse drug reactions (ADRs) that are included in the summary of product characteristics (SmPC) for drugs that have authorization to be marketed in the EU.

PROTECT is a consortium of academics, national regulators, and drug companies whose work is coordinated by the European Medicines Agency (EMA) and GlaxoSmithKline.


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