EU Medicines Agency Launches Adverse Drug Event Web Site

May 31, 2012

May 31, 2012 (London, United Kingdom) — The European Medicines Agency (EMA) has today launched a new website,, which will detail spontaneous reports of suspected side effects of medicines approved through the centralized European approvals procedure [1,2].

The reports come directly from the European Union (EU) medicines safety database, EudraVigilance, and "have not been made publicly available before," EMA press officer Monika Benstetter told heartwire . The launch of the new website is part of the agency's continuing efforts to ensure EU regulatory processes are transparent and open, she says.

Currently the site contains information relating to approximately 650 medicines, and it can be searched either by the generic name of the medicine or the proprietary product name. These are all substances approved through the central EU procedure, which grants approval in all EU member states plus those in the European Economic Area (EEA).

Benstetter notes that "not all medicines are approved through the central route." At present, information on suspected adverse drug reactions (ADRs) for products approved nationally in individual EU countries is not included on the new website, but it is hoped that it will be possible to incorporate this within the next year, she says.

The new website also gives advice on how to report a side effect; at the moment, the information is in English only, but starting in June, it will be translated into the remaining 22 official EU languages.

Reports of suspected ADRs come from patients, consumers, and healthcare professionals who report these either to the national medicines regulatory authority or the pharmaceutical company that holds the marketing authorization.

These are then submitted to EudraVigilance and now presented on the new website in the form of a single report per medicine or active substance, which pulls together the total number of individual suspected side-effect reports. These aggregated data can be viewed by age group, sex, type of suspected side effect, and outcome.

During a telephone press briefing today, Peter Arlett (head of Patient Health Protection, EMA) told heartwire that the EMA had "spoken, collaborated, and consulted" with other agencies around the world, such as the US FDA and Health Canada, on how they handle suspected ADR reports to "learn lessons and hopefully take the best bits from each."


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