EMA will allow access to its drug side effect databases

Published: 13-Jul-2011
Regulatory

Will now produce monthly reports as well as searchable reports for all medicines by end of 2012


The European Medicines Agency (EMA) will allow public access to its databases that contain information on the potential side effects of medicines. Its announcement follows criticism that EMA has been too secretive with such data.

The agency said it would start publishing monthly reports summarising information held in its EudraVigilance database for all medicines with central EMA authorisation. In addition, it will provide searchable reports for all medicines by the end of 2012.

EMA will further improve the search and data-output of these databases, supplying pharmaceutical manufacturers with tools on the ‘detection and analysis of signals on adverse reactions’ by 2015, subject to budget availability.

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