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Common Commentary on Paediatric Oncology Drug Development Published: Another Step in Optimising Global Regulatory

Dominik Karres1, Gregory Reaman2, Franca Ligas3

  • 1Paediatric Medicines Office, Human Medicines Division, Scientific Evidence Generation Department, European Medicines Agency (EMA), Amsterdam, The Netherlands. Dominik.Karres@ema.europa.eu.

Therapeutic Innovation & Regulatory Science
|September 9, 2021
PubMed

Insights

Regulatory agencies are streamlining global pediatric oncology drug development. A new joint document aims to harmonize pediatric investigation plans, facilitating early regulatory coordination and drug development timelines.

Area of Science:

  • Regulatory Affairs
  • Pediatric Oncology Drug Development
  • Global Health Policy

Background:

  • The European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have collaborated on pediatric oncology drug development.
  • Simultaneous submissions of Paediatric Investigation Plans (PIPs) and Initial Pediatric Study Plans (PSPs) are encouraged for global drug development.

Purpose of the Study:

  • To provide guidance for deliberations and focused discussions on pediatric oncology drug development.
  • To enable early regulatory coordination of global development plans through monthly "paediatric cluster calls".

Main Methods:

  • Publication of a common commentary document by the EMA and FDA.
  • Facilitation of monthly "paediatric cluster calls" for regulatory coordination.

Main Results:

  • The joint document aims to guide discussions and streamline regulatory processes.
  • Early regulatory coordination of global pediatric oncology drug development plans is facilitated.

Conclusions:

  • The commentary document supports harmonized approaches to pediatric oncology drug development.
  • Differences in regulatory timelines are not anticipated to be a barrier to coordinated global development.

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