EMA makes safety data publicly available
As part of its transparency policy, the EMA has made data on adverse reaction reports publicly available at www.adrreports.eu since May 31, 2012. This website provides access to aggregated data on adverse drug reactions submitted by national authorities and marketing authorization holders to the pan-European database EudraVigilance in accordance with legal requirements.
The number of reports per active substance can be retrieved, grouped by type and outcome, as well as by age group and gender of the affected population. In a first step, this is possible for approximately 650 active ingredients and preparations that are approved according to the centralized procedure. In a further expansion, however, the system will also provide data on nationally approved active ingredients.
The explanatory documents on the website point out that the data are reports of suspected adverse drug reactions, so that the figures retrieved do not in themselves allow any conclusions to be drawn about the actual causal relationship, the probability of the occurrence of an adverse effect, or an indication of the potential harmfulness of a drug.
