EMEA publishes Guideline on Investigation of Medicinal Products in the Term and Preterm Neonate

The Guideline which was published on 21 July 2009 was adopted by CHMP and PDCO in June 2009 and will become effective on 1 January 2010. It addresses the considerations and requirements for the design and conduct of clinical trials in premature and term neonates using medicinal products of relevance for the use by this population. It includes background information on the maturation of organs like heart and lung, and of body functions like kidney and renal function or liver and hepatic function. The particularities of the central nervous system and the immune system are also described.

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. 

Compiled by
Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)