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Pediatric Medicine Development: An Overview and Comparison of Regulatory Processes in the European Union and United

Dobromir Penkov1, Paolo Tomasi1, Irmgard Eichler1

  • 1European Medicines Agency, London, United Kingdom.

Therapeutic Innovation & Regulatory Science
|July 5, 2017
PubMed

Insights

US and EU pediatric legislation promotes global drug development for children. Understanding these regulations and incentives is key for ethical, safe, and effective pediatric medicines.

Area of Science:

  • Regulatory Science
  • Pediatric Pharmacology
  • Global Health Policy

Background:

  • International pediatric legislation, particularly in the US and EU, is a significant driver for developing pharmaceutical products for children.
  • Harmonizing global pediatric drug development requires understanding diverse legislative requirements and incentives.
  • Existing regulations aim to ensure the ethical and scientific development of medicines for pediatric populations.

Purpose of the Study:

  • To provide an overview of pediatric legislation in the United States (US) and the European Union (EU).
  • To highlight similarities and differences in legislative requirements and incentives for pediatric clinical trials.
  • To supplement existing region-specific guidance from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA).

Main Methods:

  • Comparative review of pediatric legislative frameworks in the US and EU.
  • Analysis of incentives for including pediatric patients in clinical trials.
  • Synthesis of information from FDA and EMA official documents.

Main Results:

  • Both US and EU legislation aim to incentivize and mandate the development of pharmaceutical products for pediatric use.
  • Key differences exist in the specific requirements and incentives between the US and EU regulatory bodies.
  • Understanding these legislative nuances is crucial for international drug development.

Conclusions:

  • Despite regional differences, the overarching goal of US and EU pediatric legislation is to ensure timely, ethical, and scientifically sound drug development for children.
  • Legislation facilitates the availability of safe and effective medicines for pediatric populations.
  • Harmonization efforts are essential for efficient global pediatric drug development.

Keywords:
Best Pharmaceuticals for Children Act (BPCA)EU Paediatric RegulationPaediatric CommitteePediatric Research Equity Act (PREA)Pediatric Review Committee (PeRC)

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