The Guideline is relevant to all investigations of medicinal products that include participation of the neonatal population. It does give guidance regarding the timing of development of medicinal products in neonates, special aspects of clinical trial design in neonates and the data required before the first administration to a neonate in a clinical trial.
The Guideline is based on several concept papers released by the Paediatric Working Party (PEG) addressing the impact of immaturity of different organ systems when investigating medicinal products in the neonate. It therefore contains specific aspects related to organ development that should be considered during the development of medicinal products in the neonate like formulations and route of administration and Dose-Finding.
Because the development of paediatric formulations requires specific knowledge and skills combined with dedicated pre-clinical work and the flexibility to introduce new and sophisticated dosage forms to both development and production, the ECA is addressing these challenges in detail at part 2 of the 4th ECA Good Development Practice Conference on 18-20 May 2010 in Vienna.
On behalf of the European Compliance Academy (ECA)