Essential medicines for children

Paediatric clinical trials guidance for assessors

Evidence of efficacy and safety provided by clinical trials is essential for receiving marketing authorizations for medicines in countries. However, national Regulatory Authorities receive few applications for clinical trials in children.

Trials in children can be more complex than adult trials and require different clinical and ethical considerations in their assessment.

To assist national Regulatory Authorities, regulators from Stringent Regulatory Authorities have developed guidance for assessing clinical trials in children. This document aims to improve the capacity of experienced clinical trial assessors and their agencies to assess trials in paediatric populations.