E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population


Pediatric drug development has evolved since the original ICH E11 Guideline (2000), requiring consideration of regulatory and scientific advances relevant to pediatric populations. This addendum does not alter the scope of the original guideline. ICH E11 (2000), including the present addendum (R1) is not intended to be comprehensive; other ICH guidelines, as well as documents from regulatory authorities worldwide, the World Health Organization (WHO) and pediatric societies, provide additional detail.