Paediatric regulatory network meeting report, Nairobi, Kenya, 20-21 September 2023

Overview

The aim of the meeting was to share updates, experience and good practices between members of the Paediatric Regulatory Network. The platform offered an opportunity to exchange information on paediatric regulation and achievements; to describe recent prioritization exercises, new legislation for paediatric medicines and WHO-listed authorities; Page 2 of 26 to draw on the experience of the European Medicines Agency (EMA) and United States Food and Drug Administration (US FDA); to explore, and collaborate towards, better control of substandard and falsified paediatric medicines; to discuss safety monitoring; to share best practices for clinical trials (and ethics) for paediatric medicines; and to obtain feedback and consider suggestions received from the pharmaceutical industry.