Table 5.
Main indicators before and after the Paediatric Regulation.
| Indicators | 1996–2006 | 2007–2019 | 1996–2019 |
|---|---|---|---|
| No. of new p-ASs | 106 | 175 | 281 |
| No. of new p-ASs/year | 10.6 | 14.6 | 12.7 |
| p-ASs/ASs rate | 45% | 29% | 33% |
| p-OMPs/p-MPs | 13/109 | 57/296 | 70/405 |
| No. of medicines covering the whole paediatric population | 18 (17%) | 38 (22%) | 56 (19.5%) |
| No. of ATC first-level categories covered | 14 | 14 | 14 |
| No. of paediatric antineoplastic and immunomodulating agents | 17 (16%) | 31 (18%) | 48 (17%) |
| No. of neonates and infants MPs | 26 (25%) | 37 (21%) | 63 (23%) |
| % of approved drugs including a whole clinical developmental plan (three phases) | 51.6% | 60% | 55.8% |
| % of only children trials | 52% | 53% | 52.5% |
| % of medicines approved with no paediatric trials | 8.1% | 9.1% | 8.6% |