On 21-22 June 2018, the European Medicines Agency, the Japanese Pharmaceuticals and Medical Devices Agency and the United States’ Food and Drug Administration co-organised a workshop to discuss the development of antimicrobial medicinal products and in particular antibiotics for children. This provided the possibility for international regulators to explore with medicine developers, clinicians and clinical trial investigators, clinical development plans that would allow the timely development of antibiotics for children and discuss a regulatory pathway for their approval. Moreover, the event represented an opportunity of discussion, comparison and sharing of information related to the regulatory requirements developing antibacterial agents for children in Europe, US and Japan as well as the current and future challenges with paediatric trials.
In particular, the participants discussed relevant aspects to antibacterial development in children, including challenges with conducting trials in the paediatric population (including neonates), and extrapolation of safety and efficacy data to optimise the involvement of children in clinical studies.
Finally, the meeting provided the occasion to collect further feedback on the draft EMA/CHMP Addendum to the guideline on the evaluation of medicinal products indicated for the treatment of bacterial infections to address paediatric-specific clinical data requirements (EMA/CHMP/187859/2017)(currently on public consultation until end of October 2018).
More information and the agenda of the event are available here.