PIPs – Paediatric medicines investigations

Table of contents

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). Since these plans evolve during development , tracking the agreement and progress of PIPs is an indicator of medicines planned to become available for children .

Methods

The web app 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 web app takes about 15 seconds to fully load. See the "About" tab for how to credit the EMA and for how to cite the web app.

References

European Commission. 2017. “State of Paediatric Medicines in the EU - 10 Years of the EU Paediatric Regulation.” https://ec.europa.eu/health/sites/health/files/files/paediatrics/docs/2017_childrensmedicines_report_en.pdf.
Mentzer, Dirk. 2014. “The Paediatric Regulation Meets Reality - Present and Future Challenges.” Regulatory Rapporteur, March 2014. http://embed.topra.org/regulatory-rapporteur-march-2014.


3 thoughts on “PIPs – Paediatric medicines investigations

  1. Hi Ralf, please note that once I do a search the found set never reverts to the full set, it always goes back to the last search, is that by default?

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