EMA Publishes First Update on Its Clinical Data Open Access Policy

July 17, 2018

The European Medicines Agency issued the first report on its open access policy for clinical data submitted by sponsors in their marketing applications for new drugs.

The EMA reports that it released clinical data for 50 drugs, including nine orphan drugs, six pediatric drugs, one biosimilar and 12 generics in one year following the creation of its clinical data site in October 2016. The agency published the 100th dossier on May 29, 2018.

The report also quantifies the amount of commercially confidential information (CCI) redacted, noting that only 0.01 percent of the 1.3 million pages published contained CCI redactions.

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