Off-patent paediatric priority drug list
EMEA Paediatric Committee (PDCO) revised the list of off-patent paediatric medicinal products in 2008.
The aim of Regulation (EC) 1901/2006 of the European Parliament and the Council on Medicinal Products for Paediatric Use, as amended, is to increase availability of medicines authorised for children as well as to increase the information available on the use of medicinal products in the paediatric population. The Regulation includes provisions for funding of studies into off-patent medicinal products.
In July 2008, SIOPE was requested to provide input on the EMA priority list of off-patent medicines, according to which to "the list of compounds to be studied in infants through appropriate PK/PD/PG programme has been extended to better cover the needs in both solid tumours and leukemia".
Moreover, "among the three transversal programs, we think that pharmacology in infants is the most relevant one for a US-EU funded project. There is a strong rationale to joint forces considering the rarity of the population concerned. In addition, collaboration in between EU and US is ongoing for several diseases in infants that may facilitate the implementation of a pharmacology program".
In November 2008, the two organisations also sent joint comments on the EMA concept paper regarding the development of a quality guideline on pharmaceutical development of medicines for paediatric use.