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EMA now publishing side-effects reports online

World News | June 01, 2012


Lynne Taylor

EMA now publishing side-effects reports online

The European Medicines Agency (EMA) has begun publishing suspected side effects reports for medicines authorised in the European Economic Area (EEA) on a new public website: www.adrreports.eu.

The information relates to around 650 medicines and active substances authorised through the European Union (EU) centralised approval procedure. Information on the website is presented in the form of a single report per medicine or active substance. The reports come directly from the EU medicines safety database EudraVigilance, and each report pulls together the total number of individual suspected side effect reports submitted to EudraVigilance by EU member states and marketing authorisation (MA) holders.

These aggregated data can be viewed by age group, sex, type of suspected side effect and by outcome. Within a year, the Agency aims to additionally publish suspected side effect reports for common drug substances used in nationally-authorised medicines, it says.

The EMA also notes that the launch of the new website is part of its continuing efforts to ensure EU regulatory processes are transparent and open, and is a key step in the implementation of the EudraVigilance access policy, which was approved by the EMA Management Board in December 2010.

The Agency points out that all information on the website relates to suspected side effects, and that these may or may not be related to or caused by the medicine. As a result, the published information cannot be used to determine the likelihood of experiencing a side effect or as an indication that a medicine is harmful. It asks alll users of the new website to read and accept a disclaimer explaining how to understand the information before they view a web report.

This month, the Agency will launch the new website is the remaining 22 official EU languages, it adds.


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