Regulatory Focus™ > News Articles > In New Transparency Bid, EMA Expands Drug Adverse Event Reporting Database

In New Transparency Bid, EMA Expands Drug Adverse Event Reporting Database

Posted 07 October 2014 | By Alexander Gaffney, RAC 

In New Transparency Bid, EMA Expands Drug Adverse Event Reporting Database

The European Medicines Agency (EMA) is making it easier for patients and industry to keep track of adverse events associated with medicines authorized for use by EMA and other national drug regulatory authorities.

Under a massive expansion of EMA's existing ADRreports.EU website, which houses the European database of suspected adverse drug reaction (ADR) reports, consumers can now view suspected ADR reports for drugs regardless of their centrally authorized approval status.

Previously, the database only held information about drugs approved by EMA—not national authorities.

Under pharmacovigilance legislation enacted in 2012, companies are obligated to report ADRs to EMA regardless of where the suspected event occurred within the European Economic Area (EEA). This data is, in turn, being made available on EMA's ADRreports.EU website, the agency explained.

EMA said the new system will include information on approximately 1,700 additional medicines that were not contained in the database previously.

The website supports 24 languages, including English, and includes warnings to users that all ADR reports are suspected, not necessarily causal, and should not be taken to mean the medicines are unsafe for use.

 

EMA Statement


Categories: Regulatory News

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