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Pediatric drug regulation: International perspectives

Victor C Baum1, Ralph Bax2, Dominique Heon3

  • 1Departments of Anesthesiology & Critical Care Medicine and Pediatrics, George Washington University, Washington, District of Columbia.

Paediatric Anaesthesia
|March 30, 2019
PubMed

Insights

Protecting children through research is now standard practice, evolving from past exclusion. Governments incentivize pediatric drug studies and international cooperation aids regulatory harmonization.

Area of Science:

  • Pediatric pharmacology
  • Drug regulation
  • International health policy

Background:

  • Historically, children were excluded from drug research to protect them.
  • Current approaches prioritize protecting children *through* ethical research.
  • Regulatory frameworks have evolved to mandate and incentivize pediatric drug studies.

Observation:

  • Governments offer financial incentives and impose requirements on pharmaceutical companies for pediatric drug development.
  • International collaboration involves patient representatives, regulatory agencies, and industry stakeholders.
  • Unique considerations for pediatric drug safety and efficacy are recognized globally.

Findings:

  • Pediatric drug regulation has been examined across five major international regulatory agencies.
  • The study details the evolution of pediatric drug research and regulation.
  • International cooperation efforts in pediatric drug regulation are discussed.

Implications:

  • Harmonized international pediatric drug regulations can accelerate the availability of safe and effective medicines for children.
  • Continued collaboration is crucial for addressing the specific needs of pediatric populations in drug development.
  • This research informs future policy and practice in pediatric drug approval worldwide.

Keywords:
Chinese National Drug AdministrationEU Paediatric RegulationEuropean Medicines AgencyFood and Drug AdministrationHealth CanadaPharmaceuticals and Medical Devices Agencypediatric drug regulation

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