EU Regulation on medicinal products for paediatric use
The EU Regulation on medicinal products for paediatric use was adopted in October 2006 and enforced on 26 January 2007. The aim of Regulation (EC) 1901/2006 of the European Parliament and the Council on Medicinal Products for Paediatric Use is to increase the 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.
This paediatric regulation helps improving the health of children in Europe by:
Facilitating the development and avalibility of medicines for children aged 0 to 17 years
Ensuring that medicines for use in children are of high quality, ethically researched and anthorised appropriately
Improving the availability of information on the use of medicines for children
without:
In 2008 the Paediatric Committee (PDCO) of the European Medicines Agency (EMA) revised the list of off-patent paediatric 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":
More information: