EMA Delays Decision on Clinical Trial Data until October

Jul 10, 2014

The European Medicines Agency (EMA) has postponed formal adoption of the policy on publication of clinical trial data until its October 2, 2014 meeting.

Further clarifications on the wording and practical arrangements will be discussed by members of the management board, who have confirmed their general support for 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.

The EMA says it welcomes “this additional round of joint reflections and respects all opinions, as well as the views expressed by several Member States, which largely reproduce the complexity of the debate on both political and technical aspects which have emerged during the previous general and more targeted consultation phases.” In the last 12 months, it has attempted to strike a balance between proactive data disclosure, the absolute need to protect personal data and the concerns relating to the protection of commercially confidential information.

The agency remains committed to introducing this additional measure towards transparency as soon as possible, so as to enhance public awareness and confidence in the EU authorization system for medicinal products. It also emphasizes that the new policy, if approved, will be without prejudice to the provisions of Regulation (EC) No 1049/2001 on access to documents and the new clinical trial Regulation (EC) No 536/2014, which will become applicable in 2016 at the earliest and will apply to clinical trials conducted in the EU.

Read the full release here.