Zero Success For Companies Appealing Negative CHMP Opinions In EU Last Year

26 Jan 2018

All five of the appeals against negative opinions for new drug applications that the European Medicines Agency completed last year met with failure. On the positive side, 92 new medicines were granted positive opinions, of which 35 contained new active substances.

Samples of medicines, tablets, capsules, vitamins, and placebo — Six new drugs received a negative opinion from the CHMP last year • Source: Shutterstock

Last year, five appeals against negative opinions delivered by the European Medicines Agency on initial marketing authorization applications were completed, and all five failed.

The EMA’s key scientific committee, the CHMP, handed down a total of six negative opinions relating to initial MAAs last...