An article “European drug regulators walk back on transparency promise“ has been published on March 21, 2022, on TranspariMED.
It informs how the Head of Medicines Agency has backtracked on its commitment to preparing an overview of the actions initiated by the Member States to improve the compliance/knowledge of the sponsors about making trial results public and to circulate a “best practice document” to all national drug regulators in Europe.
Some national regulators have made strong efforts to improve the trial reporting in their countries. It also provides a graphical representation of the clinical trial results uploaded in Belgium in the year 2020-2021.
However, other regulators like the Italian regulator AITA appear not to have taken any action. It mentions that from the 102 drug trials by the National Cancer Institute in Italy, not even one single trial result has been made public in EudraCT which violates the transparency rules.
A total of five health groups have written a letter to the Heads of Medicine Agencies urging them to deliver on their promise.