EMA private-public project releases pharma databases

Published: 28-Feb-2013
Regulatory

Including the Drug Consumption Database and the PROTECT ADR database


Pharmaceutical companies seeking pharmacovigilance and pharmacoepidemiology information from across the European Union (EU) can now consult two new databases.

Created by the public-private partnership PROTECT project, they are the Drug Consumption Database and the PROTECT ADR [adverse drug reaction] database.

The former comprehensively structures European drug consumption data from Belgium, Britain, Bulgaria, the Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Latvia, the Netherlands, Norway, Poland, Portugal, Spain and Sweden.

The latter lists all ADRs contained in product characteristic summaries of all medicinal products with EU central authorisations. Its goal is to ‘improve the efficiency of the detection process of ADRs by allowing quick identification and filtering or flagging of listed and unlisted ADR’, said EMA. The database will be updated every six months.

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