Open letter from the European Medicines Agency

“Our activities in relation to COVID-19 deserve the highest possible level of transparency and, in keeping with our commitment, the Agency will take appropriate action to share information publicly. We are currently discussing how to enhance the level of transparency for COVID-19 procedures, including the possibility of rapidly publishing clinical data for these products. The need for rapid evaluation during the current emergency will require us to depart from our usual procedures. In some cases, we will be evaluating evidence as it emerges (i.e. ‘rolling review’) and putting information in the public domain in these circumstances will be subject to additional challenges which we are currently looking to address….

Inevitably, this disruption [Brexit] required the Agency to shift all its focus to core activities that are essential for public health. Regrettably, our efforts to publish clinical data had to be put on hold in these very trying circumstances. 

In view of this and the extra effort needed to deal with COVID-19 related activities, I can’t yet commit

to reinitiate all activities related to clinical data publishing for medicines evaluated by the Agency.

However, as stated above, COVID-19 related medicines deserve special consideration because of the

overriding public interest and the need to support the international research community and foster the

collaborative effort. Further information on the concrete proposals to increase transparency of COVID19 related activities will be communicated once agreed within EMA and the EU Regulatory Network….”