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International Collaboration / Pediatric Cluster

The FDA engages in international collaborative exchanges with other regulatory agencies to help facilitate global development of medical products for children. The objective of these exchanges is to help ensure pediatric studies are conducted in a scientifically rigorous and ethical manner and that pediatric patients are not exposed to unnecessary or duplicative clinical trials.

Pediatric legislation in the United States and Europe drives pediatric medical product development on a global scale. Global collaboration is important in the development of pediatric programs that are optimally designed to support pediatric marketing applications for medical products worldwide.

About the Pediatric Cluster

In 2007, the FDA and the European Medicines Agency (EMA) established monthly teleconferences among regulators called the Pediatric Cluster to discuss product-specific pediatric development and general topics related to product classes under the terms of a Confidentiality Commitment (view applicable Commitments under Related Links below). Since inception, other international agencies have become members of the Pediatric Cluster, which now includes five international regulatory agencies.

This collaboration provides a robust forum to discuss ethical, scientific, and regulatory issues related to global pediatric medical product development. The Pediatric Cluster teleconferences are usually held monthly, although additional teleconferences may be held to accommodate different agency review timelines. 

Pediatric Cluster Members

  • U.S. Food and Drug Administration (FDA) (founding member, 2007)
  • European Medicines Agency (EMA) (founding member, 2007)
  • Japan's Pharmaceuticals and Medical Devices Agency (PMDA) (joined 2009)
  • Health Canada (joined 2010)
  • Australia's Therapeutic Goods Administration (TGA) (joined 2014)

Pediatric Cluster Objectives

  • Facilitate the regular exchange of information related to scientific and ethical issues and other information on pediatric product development programs that have been submitted to regulatory agencies in Australia, Canada, the European Union, Japan, and the United States 
    • This includes development programs submitted in response to pediatric legislation and regulations such as Pediatric Investigation Plans (PIPs) [EMA], Pediatric Study Plans (PSPs) [FDA], and Proposed Pediatric Study Requests (PPSRs) [FDA] 
  • Encourage global pediatric product development that is compatible with the pediatric legislation and regulations within Australia, Canada, the European Union, Japan, and the United States
  • Understand the scientific rationale when divergences in opinions exist between regulatory agencies
  • Discuss post-marketing pediatric requirements and issues including risk management and plans for long-term pediatric safety monitoring
  • Discuss general topics of regulatory and scientific interest to the participating agencies
  • Inform participants and encourage attendance at planned scientific meetings or workshops related to pediatric matters 

Discussion Topics

The monthly discussions at the Pediatric Cluster include issues pertaining to product classes and to product-specific development that arise during the regulatory life cycle (pre- and post-marketing). Examples of issues for discussion at the Pediatric Cluster include:

  • Plans for waiving or deferring pediatric assessments otherwise required by law or regulation
  • Proposals for determining pediatric dosing, including proposed clinical pharmacology studies and plans for the use of modeling and simulation
  • Proposed endpoints to evaluate efficacy or safety in a pediatric clinical trial(s) 
  • Ethical issues specific to pediatric trial design, including consideration for differences in standard clinical practice or disease prevalence in different jurisdictions
  • Extrapolation of data (e.g., from adults) to support efficacy and safety for a proposed pediatric population
  • Indications/conditions for study in pediatric populations
  • Safety concerns related to pediatric populations, specific drug classes, product development and clinical trials, including safety issues identified in nonclinical toxicology studies
  • Pediatric formulation requirements and issues
  • Patient population proposed for inclusion in a clinical trial(s), including the appropriate age ranges to include
  • Aspects of clinical trial design to aid in an optimally designed trial to support pediatric labeling

In 2018, the FDA and EMA began sharing high-level action items directly with product sponsors to let sponsors know that their product was discussed at the Pediatric Cluster and to convey the agreed-upon action.

Common Commentary

In 2012, the FDA and EMA began issuing Common Commentaries to share unofficial, high-level comments reflecting FDA and EMA subject matter expert discussion at the Pediatric Cluster teleconference. The purpose of a Common Commentary is to help medical product sponsors achieve globally harmonized pediatric product development plans.

Common Commentaries may be issued publicly for general topics pertaining to pediatric medical product development or confidentially to sponsors for selected products where pediatric study plans are under consideration by both agencies. Common Commentaries are meant to highlight scientific or regulatory issues where the FDA and EMA are working toward, or have achieved, a harmonized view. Common Commentaries may also provide clarity to sponsors by outlining important areas where the FDA and EMA may be unable to align. 

Common Commentaries

Pediatric Cluster Member Agency Links

Related Links

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