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Paediatric Regulation in the European Union: an overview

Paolo Caferra1, Thomas Fraisse2, Veronica Baffa3

  • 1Department of Pharmacy, University of Pisa, Via Bonanno, 6, 56126 Pisa, Italy; Research and Development, Sanofi, Paasheuvelweg 25, 1105 BP Amsterdam, the Netherlands.

Drug Discovery Today
|August 18, 2026
PubMed

Insights

Paediatric Investigation Plans (PIPs) ensure medicines are studied for children. This review examines the PIPs, waivers, and deferrals framework and upcoming pharma package changes.

Area of Science:

  • Regulatory Science
  • Pediatric Pharmacology
  • European Union Law

Background:

  • Paediatric Investigation Plans (PIPs) are mandated by the EU Paediatric Regulation (EC) no. 1901/2006.
  • PIPs are essential for ensuring medicines are appropriately studied, developed, and authorized for pediatric use.
  • The regulation requires PIP data for new marketing authorization applications and line extensions, unless waivers or deferrals are granted.

Purpose of the Study:

  • To explore the regulatory framework of PIPs, waivers, and deferrals for both on-patent and off-patent drugs.
  • To provide an overview of anticipated changes within the new 'pharma package' concerning pediatric medicines.

Main Methods:

  • Literature review of the existing regulatory framework for PIPs.
  • Analysis of the Paediatric Regulation (EC) no. 1901/2006.
  • Exploration of waiver and deferral provisions within the regulatory landscape.

Main Results:

  • The current framework mandates PIPs for pediatric drug development, with specific provisions for waivers and deferrals.
  • The review highlights the importance of PIPs in addressing data gaps for pediatric populations.
  • Anticipated changes in the upcoming 'pharma package' are expected to further refine the regulatory landscape for pediatric medicines.

Conclusions:

  • The PIPs framework is a cornerstone of pediatric drug regulation in the EU.
  • Understanding waivers and deferrals is crucial for efficient drug development in children.
  • The upcoming 'pharma package' signifies a continued commitment to advancing pediatric medicine regulation.

Keywords:
Paediatric Investigation PlanRegulation (EC) no. 1901/2006deferraldrug development childrennew European pharmaceutical legislationwaiver

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