EMA: Ringelpiez with touching

13.06.2014 10:49

The EMA guidelines for the publication of clinical trial data have been finalized. Third parties are now permitted to edit the data, not just view it. Scientists, independent institutions, and not least the European Ombudsman Emily O'Reilly recently put pressure on the EMA because it wanted to deviate from its transparency policy and only guarantee "view-on-screen" access. The agency plans to officially adopt its guidelines on transparency policy in the coming weeks.

According to the press release from the European Medicines Agency (EMA), third parties may not only view the study data for academic purposes, but also download, save, and print it. According to the EMA, Executive Director Guido Rasi proposed the "user-friendly changes," which are included in the Final version of the guidelines. The study data that the EMA intends to release are submitted by pharmaceutical companies as part of their marketing authorization applications for new drugs.

However, the exact written wording, including the practical rules for data use, will not be finalized until mid-July 2014, according to the EMA. The EMA paper is scheduled to enter into force on October 1, 2014.

The agency emphasizes that it wants to achieve the broadest possible consensus among the opposing interest groups. The public consultation phase took place between June and September 2013 and entered its second round in May 2014. According to the EMA, there was broad support for the transparency policy overall, but also concerns regarding the so-called "view-on-screen-only" access to the study data.

EMA response to the objections of scientists and independent institutions to the “view-on-screen-only” policy.