The European Medicines Agency (EMA) receives comprehensive clinical study data from drug manufacturers. These data form the basis for the decision on the approval of new drugs. To make this information available to researchers and decision-makers, EMA issued a draft policy in 2013 for the publication of clinical study data, in which extensive data transparency was planned.

Besides other interested parties, the German Institute for Quality and Efficiency in Health Care (IQWiG) was intensely involved in the subsequent consultations. The result of these consultations is all the more disappointing; in particular the draft on the conditions of use for the EMA interface via which anyone should be able to access the data.

For more details, go to: https://www.iqwig.de/en/press/further_news/further_news/just_look_but_don_t_touch_ema_terms_of_use_for_clinical_study_data_are_impracticable.6121.html