ICH E11(R1) - Clinical Investigation of Medicinal Products in the Pediatric Population

What it says

E11 and its addendum provide an outline of the critical issues in pediatric drug development and approaches to the safe, efficient and ethical study of medicinal products in the pediatric population. It covers when to start studies in children, types of studies, age categories, formulation, ethical considerations and the use of extrapolation from adult or other data where appropriate.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Children are not small adults, so dosing, formulation and endpoints may differ from those in adults.
• Ethical safeguards such as minimizing pain, distress and the number of procedures apply.
• Extrapolation can reduce the need for some studies when disease and response are similar.

What inspectors look for

• Whether the study design is appropriate for the age group.
• Whether consent and assent are handled properly.
• Whether the rationale for any extrapolation is documented.

Related regulations