EMA agrees policy on publication of clinical trial data with more user-friendly amendments

The European Medicines Agency management board agreed the policy on publication of clinical trial data, together with more user-friendly amendments proposed by EMA executive director Guido Rasi.

The proposed policy will not only allow the Agency to proactively publish clinical trial data that are submitted as part of marketing authorization 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 finalized with a view to its adoption by the board through written procedure by mid-July 2014, and will be effective from October 1, 2014. Importantly, the Agency will ensure that the policy will not prejudice citizens’ rights under existing access to documents legislation and the new clinical trials regulation.