EMEA WORKING TOWARD GUIDANCE ON NEONATAL DRUG DEVELOPMENT

The development of safe and effective medicines for newborn babies requires stronger cooperation between researchers, developers and regulators. This was one of the main conclusions of a workshop organized by the European Medicines Agency (EMEA) that looked at scientific issues related to the investigation of medicinal products intended for the treatment of neonates. The outcome of the workshop — together with a series of concept papers on the impact of brain, liver, kidney, heart and lung immaturity prepared by the agency's Paediatric Working Party — will form the basis of a future EMEA guidance on this issue.

Highlighting the agency's commitment to stimulate multidisciplinary cooperation in the development of medicines for children, the workshop brought together roughly 70 experts from academia and learned societies, industry and regulatory authorities, and also healthcare professionals involved in looking after and treating newborn babies, including premature babies. The participants discussed the impact of organ immaturity and the rapid changes in the first days and weeks of life when investigating medicines for neonates.

Other aspects covered during the workshop included formulations appropriate for neonates, ethical aspects in relation to the conduct of clinical trials in newborn babies, novel study design methods and safety and pharmacovigilance aspects. It is expected that this will result in an increase of clinical trials in children, including neonates.