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Biosensor-based High Throughput Biopanning and Bioinformatics Analysis Strategy for the Global Validation of Drug-protein Interactions
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Global Pediatric Drug Development

Mette Due Theilade Thomsen1

  • 1PIP Adviser, Lyngby, Denmark.

Current Therapeutic Research, Clinical and Experimental
|August 8, 2019
PubMed

Insights

Global pediatric drug development is evolving. Recent initiatives from the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) are paving the way for harmonized pediatric development plans.

Area of Science:

  • Regulatory Science
  • Pediatric Drug Development
  • Global Health Policy

Background:

  • The European Union Paediatric Regulation (2007) and existing US legislation guide pediatric drug development.
  • Significant differences and similarities exist between EU and US pediatric regulatory frameworks.
  • Achieving a globally harmonized pediatric development plan is a key objective.

Purpose of the Study:

  • To investigate methods for successful pediatric medicine development that satisfy both regulatory authorities and sponsors.
  • To analyze case examples of global harmonized pediatric development plans.
  • To provide insights into overcoming challenges in international pediatric drug development.

Main Methods:

  • Comparative analysis of European Union and United States pediatric legislation.
  • Discussion of case studies involving the achievement of global harmonized pediatric development plans.
  • Examination of recent initiatives by regulatory bodies.

Main Results:

  • Case studies highlight challenges in achieving globally aligned pediatric plan development.
  • Recent initiatives from the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) are actively addressing these challenges.
  • Progress has been made towards global harmonization in pediatric drug development.

Conclusions:

  • Global pediatric drug development is a dynamic and evolving field.
  • The goal of harmonized pediatric development plans is attainable with current regulatory efforts.
  • Collaboration between regulatory agencies like the EMA and FDA is crucial for future success.
Abstract

Keywords:
European Medicines AgencyFood and Drug AdministrationGlobally aligned pediatric drug developmentPaediatric Investigation PlanPediatric study planPediatrics

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