On 17 September, the European Medicine Agency (EMA) published a concept paper on the need for a revision of the guideline on the investigation of medicinal products in the term and preterm neonate.
Interestingly this concept paper has addressed computer modelling in the critical aspects related to the update of the guidance document: “PK/PD extrapolation, modeling and simulation approaches, supporting dose selection and extrapolation of efficacy from other age groups has evolved significantly over the last years and must be correctly addressed. Extrapolation of safety from other age groups to neonate is usually not possible, but should be considered where available evidence is supportive.”
Comments and feedback on this concept paper can be submitted through a public consultation that was launched by the EMA until the 16 December. EMA has planned to release for consultation a draft guidance document no later than Q4 2020.
Term and preterm neonates are the most vulnerable subgroup of the paediatric population with the highest rate of unauthorised or off-label used medicines across the entire paediatric population. The Guideline on the investigation of medicinal products in the term and preterm neonates entered into effect in 2010 (EMEA/536810/2008).
For more information, the concept paper can be found here.