EMA delays formal adoption of publication of clinical trial data policy

The European Medicines Agency management board has postponed formal adoption of the policy on publication of clinical trial data to its meeting on October 2.

Further clarifications on wording and practical arrangements will be discussed by board members, who have confirmed their general support to the overall aims and objectives of the policy, including the more user-friendly amendments proposed by EMA executive director Guido Rasi that would allow data to be downloaded, saved or printed for academic and non-commercial research purposes.

Further to the agreement reached with the European Commission in accordance with Article 80 of Regulation (EC) No 726/2004, the EMA board was not able to conclude on the final wording of the policy through a written procedure. Members of the board have offered additional valuable contributions which will now be considered and addressed in the next few weeks, with a view to reaching final agreement at the next management board meeting in October.