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EMA presents new policy on clinical trial data

The European Medicines Agency has agreed on policy on publication of clinical trial data with more user-friendly amendments.

This will not only allow the Agency to proactively publish clinical trial data that are submitted as part of marketing authorisation applications, but also give the possibility to download, save and print the trial data for academic and non-commercial research purposes.

In light of discussions at the Board, the wording of the policy, including practical arrangements for academic and non-commercial research users, will now be finalised with a view to its adoption by the Board through written procedure by mid-July 2014, and will be effective from 1 October 2014.

Source: EMA