Navigating the Development of Pediatric Plans

Regulatory Focus
August 2018
Rajendra Wable, Sciformix – A Covance Company

This article details a practical overview of the information that should be included within a pediatric plan, focusing on EU regulations with a comparison to the legislation issued by FDA. The author examines the common mistakes and misunderstandings that can occur when submitting such documents.

Introduction for all new medicines seeking Marketing Authorization (MA) in the EU and US, pediatric plans must be submitted, with exceptions in some instance, i.e., FDA recognizes some diseases that do not require pediatric studies (Alzheimer’s for instance), to ensure medicines for children are included in the mainstream drug development process. Other major regulators also are beginning to mandate the inclusion of pediatric studies within marketing authorization applications.

These documents are referred to as Pediatric Investigation Plans (PIPs) in the EU and Pediatric Study Plans (PSP) in the US, yet both look to achieve very similar objectives. The requirements by regulatory agencies are aimed at ensuring the necessary data are obtained and evaluated for medicines to be used in pediatric patients to guarantee that children have access to the medicines required and they are effective and safe for them to use.{1} In this article, the generic term pediatric plans is used when referring to both sets of regulations.

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