May 14, 2020
All clinical trial data on Covid-19 medicines and vaccines should be published on the day of marketing authorisation!
Open letter to the European Medicines Agency
Researchers from IQWiG and the call on the European Medicines Agency (EMA) to publish all Clinical Study Reports on all Covid-19 medicines and vaccines immediately on the day of marketing authorisation. In an open letter to EMA Director Professor Guido Rasi, the researchers state that the international research community has joined forces to identify or develop, test and evaluate medicines and vaccines to fight the pandemic and that “to assess these products further and to accelerate the development of additional products, the fast and full public availability of the information submitted to regulators is of utmost importance.” They also note that EMA has been a pioneer of data transparency among regulatory agencies in the past few years and that exactly this transparency is currently needed.
EMA has recently started an accelerated authorisation process for the antiviral drug remdesivir.