EMA’s Clinical Data Publication Initiative Hits One-Year Mark

The European Medicines Agency published more than 3,000 clinical documents over the past year, since becoming the first regulatory authority to provide open access to clinical data in October 2016.

At the one-year anniversary of the transparency initiative, which covers clinical study reports and other documents submitted by companies in marketing applications, the agency has registered more than 3,600 users.

Documents are now available for 50 medicines, including orphan drugs, biosimilars and generics, totaling more than 1.3 million pages. The majority of the data relates to the approval of new medicines, but also covers label extensions and rejected applications.