Existing Guidelines

The European Commission and the European Medicines Agency (EMEA) both provide many guidelines for the industry. http://www.emea.europa.eu/htms/human/humanguidelines/background.htm

According to EMEA’s Reflection Paper on “Formulations of choice for the pediatric population” (Ref EMEA/CHMP/PEG/194810/2005), oral liquid formulations can apply to all age groups. It is the intention of the consortium to explore this formulation in all subsets through this development program.

Experts have identified the need to develop adequate formulation for children and have provided a reflection paper giving guidance for the development of pediatric formulations. MTX / 6MP pediatric formulations were identified as a priority (EMEA/197972/2007).