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Paediatric drug development: the impact of evolving regulations

M A Turner1, M Catapano2, S Hirschfeld3

  • 1University of Liverpool, Department of Women's and Children's Health, Institute of Translational Medicine, Liverpool Women's NHS Foundation Trust, Crown Street, Liverpool L8 7SS, UK.

Advanced Drug Delivery Reviews
|February 22, 2014
PubMed

Insights

Developing medicines for children requires significant effort within existing regulatory frameworks. This review examines paediatric drug development progress and outlines future directions for optimizing children's medicine accessibility.

Area of Science:

  • Paediatric pharmacology
  • Regulatory science
  • Drug development

Background:

  • Increasing recognition of the need for child-adapted medicines over recent decades.
  • Established legal and regulatory frameworks in the EU and US support paediatric drug development.
  • Significant advancements in paediatric drug development work compared to 10 years ago.

Purpose of the Study:

  • To critically appraise the evolution of paediatric medicine development within existing legal and regulatory frameworks.
  • To identify how current practices can be generalized for broader application.
  • To outline current work and future opportunities in paediatric drug development.

Main Methods:

  • Review of the development of medicines for children.
  • Critical appraisal of work conducted within established regulatory frameworks.
  • Utilizing the Global Research in Paediatrics (GRiP) Network of Excellence's work programme as a template.

Main Results:

  • Proof-of-concept established across all segments of the paediatric drug development pipeline.
  • Increased volume of work in paediatric medicine studies.
  • Current regulatory frameworks offer potential that requires significant effort to fully realize.

Conclusions:

  • Despite progress, substantial effort is needed to maximize the potential of current regulatory frameworks for paediatric drug development.
  • Generalizing successful paediatric drug development practices is crucial.
  • Future work should focus on optimizing the pipeline based on established frameworks and ongoing research networks.

Keywords:
Children's medicineExtrapolationPharmaceutical developmentPharmacodynamicsPharmacokineticsRegulatory frameworkRisk benefit ratio

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