Regulatory Focus™ > News Articles > New EMA-Run Website Looks to Boost Adverse Event Reporting Transparency

New EMA-Run Website Looks to Boost Adverse Event Reporting Transparency

Posted 31 May 2012 | By Alexander Gaffney, RAC 

The European Medicines Agency (EMA) is looking to enhance its transparency measures surrounding the receipt and publication of adverse event reports for all medicines authorized in the European Economic Area (EEA) through a brand-new website.

The website,, is linked up with EMA's EudraVigilance adverse event reporting database and already contains information on more than 650 medicines authorized through the centralized procedure. Each report on the website contains a listing of all side effects reported to EudraVigilance through Members States and marketing authorization holders (MAHs), which can further be broken down by patient attributes.

For instance, a report on the recently-reaffirmed drug Pradaxa shows a total of 6,719 suspected adverse event reports, with the majority occurring in those between the ages of 65 and 85 (2,907). Cases were relatively evenly split between male and female patients (2,793 vs. 2,928), but occurred primarily in non-EEA regions (5,258 cases).

EMA said in a statement the launch of the website "highlights the importance of side effect reporting and pharmacovigilance in safeguarding public health within the EU."

"Side-effect reporting is a key element in ensuring the detection of new or changing safety issues, and the Agency continues to further strengthen its work with partners and stakeholders across Europe to ensure a robust system for safety signal detection," added the agency.

Read more:

EMA - European Medicines Agency boosts EU transparency with online publication of suspected side effect reports

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