Background
The development and authorisation of medicines for children is regulated and incentivised in Europe. Paediatric investigation plans (PIPs) reflect the studies required by the Paediatric Committee (PDCO) of the European Medicines Agency (EMA). The studies may need to involve newborns (Bax and Tomasi 2015), infants, children and / or adolescents (Penkov et al. 2017), for scientific and medical reasons. Since these plans evolve during development (Mentzer, Desfontaine, and Tomasi 2014), tracking the agreement and progress of PIPs is an indicator of medicines planned to become available for children (European Commission 2017).
Methods
The webapp shows information that is daily automatically extracted from decisions made publicly available by the EMA. Users can track PIPs of interest to be presented in tables and visualisations. Available information concerns study designs, discontinuations, overall timelines, modifications, therapeutic area, indications, compliance opinions; clinical trials and marketing authorisation will be included.
For more insights and technical access, an application programming interface (API) can be provided upon request. The webapp takes several seconds to fully load. See the “About” tab for how to credit the EMA and for how to cite the webapp.