As for scientific advice (SA) activities and protocol assistance (PA), in 2022 the European Medicines Agency provided 146 SA/PA on paediatric-only and combined adult and paediatric medicines development. The data are in line with those observed since 2016, with some decrement with respect to 2021 (220). The number of SA/PA without paediatric aspects remained almost stable (687 in 2022, vs 602 in 2020 and 632 in 2021). 

EMA’s 2022 annual report to the European Commission was elaborated on the basis of data made available from 26 national patent offices, and referred to the six-months extension of the  supplementary protection certificates (SPC) granted for paediatric development. In 2022, 44 active substances including fixed-dosed combinations (FDC) benefited from the six-month extension. No paediatric use marketing authorisation (PUMA) was granted, while four orphan medicines benefited from a two-year extension of their market exclusivity. 

According to the report, in 2022 a total of 129 Paediatric Investigation Plans (PIPs) received a positive opinion and 113 full product-specific waivers were granted.