Current Edition

Improving Medicines for Children with Advancements in Paediatric Clinical Research

Much progress has been made in paediatric medication development since the implementation of paediatric legislation in the US and EU. Marketing authorisation for new medicines, as well as applications for modification of existing registrations under patent, must include paediatric assessments as described in a paediatric study plan, unless it is exempt due to deferral or waiver, or the medicine does not fall under the scope of the paediatric regulations. Dr Martine DehlingerKremer of Synteract asks: how are regulatory authorities working to improve paediatric drug development?