Table 1 Summary scorecard of EMA assessment of 68 MAAs*
From: Factors influencing non-approval of new drugs in Europe
Development plan | Clinical outcome | Clinical relevance | Non-approved (n = 23) | Approved (n = 45) |
|---|---|---|---|---|
+ | + | + | 0 | 8 |
+ | + | − | 0 | 6 |
+ | − | + | 0 | 2 |
+ | − | − | 2 | 0 |
− | + | + | 2 | 18 |
− | + | − | 2 | 6 |
− | − | + | 5 | 3 |
− | − | − | 12 | 2 |
EMA, European Medicines Agency; MAA, marketing authorization application. *Definitions of positive (+) and negative (−) scores are given in Supplementary information S2 (box). | ||||
