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). The studies may need to involve newborns , infants, children and / or adolescents , for scientific and medical reasons. 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

Penkov, Dobromir, Paolo Tomasi, Irmgard Eichler, Dianne Murphy, Lynne P. Yao, and Jean Temeck. 2017. “Pediatric Medicine Development: An Overview and Comparison of Regulatory Processes in the European Union and United States.” Therapeutic Innovation & Regulatory Science 51 (3): 360–71. https://doi.org/10.1177/2168479017696265.
Bax, Ralph, and Paolo Tomasi. 2015. “Neonatal Pharmacotherapy: Legal and Regulatory Issues.” Neonatal Pharmacology and Nutrition Update 18: 108–23. https://doi.org/10.1159/000365035.
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.


4 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?

  2. A note to all about the the webapp: It has been updated to recent changes in the data source. As of today, the PIP webapp contains more than 1150 agreed PIPs, each with one or more modifications, and 885 waivers. The automatic updates still happen every evening, adding any new decisions, discontinuations and compliance opinions right when published by the EMA. Check it out!

Leave a Reply to Raphaël Rousseau Cancel reply

Your email address will not be published.