Press Release: European Medicines Agency boosts EU transparency with online publication of suspected side effect reports

The European Medicines Agency (EMA), on 31 May 2012, began publishing suspected side effect reports for medicines authorised in the European Economic Area (EEA) on a new public website: www.adrreports.eu. The reports come directly from the European Union medicines safety database EudraVigilance and are one of the many types of data used by regulators to monitor the benefits and risks of a medicine once authorised. The launch of the new website is part of the Agency’s continuing efforts to ensure EU regulatory processes are transparent and open and is a key step in the implementation of the EudraVigilance access policy.

The information published on 31 May relates to approximately 650 medicines and active substances authorised through the centralised procedure, which is managed by the Agency. Within a year the Agency aims to additionally publish suspected side effect reports for common drug substances used in nationally authorised medicines.

• Primary Source

EMA: Press Release: EMA/258738/2012 (31.5.12): European Medicines Agency boosts EU transparency with online publication of suspected side effect reports http://www.emea.europa.eu/docs/en_GB/document_library/Press_release/2012/05/WC500127957.pdf

Website: European database of suspected adverse drug reaction reports http://www.adrreports.eu/

---