Essential medicines and health products

Regulation of medicine for children

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.

Paediatric medicines regulatory network (PmRN)

The PmRN supports availability of quality medicines for children through facilitation of communication, collaboration and regulatory harmonization across manufacturing, licensing and research. The network is composed of representatives from National Medicines Regulatory Authorities and all regulators are free to join. Through the network information is shared and the transparency of the decision making process is improved. In addition, the network promotes appropriate ethical and clinical research standards for children, strengthens paediatric pharmacovigilance and contributes to capacity building for the licensing of paediatric medicines.

For further information, Member States can contact: