EMA’s PRIME A Year On: Hits And Misses When It Comes To Applications

Three out of four applications have been denied entry to the European Medicines Agency’s priority medicines (PRIME) scheme for getting drugs for unmet medical needs to patients faster. Robert Hemmings, who chairs the EMA’s scientific advice working party, explains why.

Arrows — Many applications for the EMA's PRIME scheme miss the mark • Source: Shutterstock

Weak pharmacological rationale. Issues with the robustness of data including the use of comparisons to inadequate historical control data. Failure to justify a therapeutic advantage.

These are some of main reasons almost three out of four applications have been denied entry on the European Medicines...