PIPs – Paediatric medicines investigations

A searchable webapp showing details of development plans (PIPs), updated at least once a week
dataset
procedures
Author

Ralf Herold

Published

2025-04-26

Modified

2025-11-06

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 automatically extracted at least once a week 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.

Webapp

Maximise

Changes

  • 2025-11-08 further adaptation to new numbering
  • 2025-10-18 first adaptation to new numbering (EMA/PE/…, EMADOC-…)
  • 2025-04-18 adapt to EMA webserver change
  • 2025-02-02 update to EMA website changes
  • 2024-08-14 added searching EPARs for PIP Decision numbers
  • 2024-08-14 added cases missing due to partial information
  • 2024-03-28 accommodated source XLS file outdated on EMA website
  • 2023-12-10 updated to new EMA website
  • 2023-07-13 mitigate PDF metadata errors
  • 2023-05-13 system update
  • 2022-10-01 faster webapp start
  • 2021-06-11 better aligning conditions and indications
  • 2021-05-30 harmonised PIP completion plots
  • 2020-04-26 updated to EMA website changes
  • 2019-12-07 improved discontinuation date detection
  • 2019-06-29 improved user interface
  • 2019-06-06 improved extracting PDF contents
  • 2018-11-25 revised into Shiny app
  • 2018-11-01 adapted to revised source website
  • 2018-09-09 divided by condition, column selection
  • 2018-08-15 added access to decision files
  • 2018-08-12 added summary and completion tabs
  • 2018-07-11 show studies by modification
  • 2018-07-07 show applicant
  • 2018-01-07 initial release

References

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, Emilie Desfontaine, and Paolo A Tomasi. 2014. “The importance and challenge of pediatric trials of hemophilia drugs.” Nature medicine 20 (5): 465. https://doi.org/10.1038/nm.3546.
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.