The European Medicines Agency (EMA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and the United States' Food and Drug Administration (FDA) are co-organising a workshop to discuss the development of antibiotics for children.
The workshop will take place at EMA’s premises in London on 21-22 June 2018.
The workshop will provide an opportunity for international regulators to explore with medicine developers, clinicians and clinical trial investigators, clinical development plans that would allow for the timely development of antibiotics for children and discuss a regulatory pathway for their approval.
The workshop will be broadcast live on the EMA website. An agenda of the event is available.
In light of the emergence of antimicrobial resistance as a major global public health threat, there is an urgent need to develop new medicines to treat infections caused by bacteria that have become resistant to most antibacterial agents currently available. Children are also affected by infections caused by these resistant bacteria and are equally in need of new therapeutic options. As pediatric development often takes several years after initial approval of medicines in adults, timely planning and conduct of fit-for-purpose pediatric studies is key to generate sufficient evidence to allow regulatory decisions and ultimately timely access to antibiotics for children who need them.
Highlights to be discussed at the workshop include: challenges with conducting trials in children; extrapolation of safety and efficacy data to optimise the involvement of children in clinical studies; and studies in newborn babies.
The workshop will also allow EMA to gather further feedback on its ‘addendum to the guideline on the evaluation of medicinal products indicated for the treatment of bacterial infections to address paediatric-specific clinical data requirements’. The document, which is out for public consultation until end October 2018, will provide specific guidance on pediatric clinical development programmes to support the authorisation of antibiotics for children.
The event is organised in the context of a series of tripartite meetings between EMA, PMDA and the FDA on the development of antibiotics. Stimulating and facilitating the development of new antibiotics is one of the European Commission's priorities to fight antimicrobial resistance and a crucial element of EMA’s work in this area.