PIPs – Paediatric medicines investigations

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.

These plans evolve during execution and development (Mentzer, Desfontaine, and Tomasi 2014), and tracking the agreement and progress of PIPs (for example, see webapp tab “Completion”) is an indicator of medicines planned to become available for children (European Commission 2017). A recent study reports on the progress of pediatric studies required in the US (McGonigle et al. 2025).

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, progress to completion, discontinuations, overall timelines, modifications, therapeutic area, indications, compliance opinions, links to search for paediatric data in marketing authorisations.

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

2026-01-14 address some aberrant source documents
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2024-03-28 accommodated source XLS file outdated on EMA website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.

McGonigle, Rylee, Huseyin Naci, Maximilian Siebert, Michelle Ouvina, Alba Gutiérrez-Sacristán, Anita K. Wagner, and Florence T. Bourgeois. 2025. “Pediatric Studies and Labeling Additions Required by the U.S. FDA for Novel Drugs Approved from 2011 to 2023: A Retrospective Cohort Study.” PLOS Medicine 22 (12): e1004651. https://doi.org/10.1371/journal.pmed.1004651.

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.