FDAnews Drug Daily Bulletin


April 26, 2006

The number of drug safety reports filed with the European Medicines Agency (EMEA) increased dramatically last year with the implementation of mandatory electronic filing, according to the EMEA's annual report.

The EMEA said it received 42,120 adverse drug reports in 2005, compared to 18,174 in 2004 and 15,017 in 2003.

As of November 2005, drug developers and clinical trial sponsors were required to file drug safety reports into the EudraVigilance database, the EMEA said.

Health officials and companies with approved drugs must also electronically file post-marketing authorization reports into EudraVigilance. These stakeholders sent a total of 144,786 individual case safety reports (ICSRs) originating from within and outside the European Union, the report said. Eighty percent of the more than 42,000 adverse drug reaction reports received in 2005 were from these postmarket reports.

In addition, 67 sponsors of clinical trials within the European Economic Area reported a total of 34,352 suspected unexpected serious adverse reactions into EudraVigilance.

Stakeholders also filed 32,842 retroactive electronic filings, according to the EMEA. At the end of 2005, EudraVigilance contained 524,782 ICSRs, corresponding to 203,844 individual cases.

The report can be found at: http://www.emea.eu.int/pdfs/general/direct/emeaar/AnnualReport2005.pdf (http://www.emea.eu.int/pdfs/general/direct/emeaar/AnnualReport2005.pdf).