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a doctor examines a small child with a stethoscope

In 2000, the International Conference on Harmonisation (ICH) finalized international guidelines that addressed the conduct of clinical trials of medicines in pediatric populations.

The guidelines facilitate the safe and effective use of medicinal products in pediatric patients. As a result, FDA adapted this guideline based on the general principles of ICH E-11, including:

  • Pediatric patients should be given medicines that have been properly evaluated for use in the pediatric population.
  • Product development programs should include pediatric studies when appropriate.
  • Pediatric product development should not delay adult studies or the availability of drugs for adult patients.

Apart from the guidance, companies, regulatory authorities, health professionals and society have a shared responsibility for including pediatric patients in drug development.

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