Medicines and children: children medicines qualification project.
From 1st October 2004, less than two months after its juridical status was recognized, MedChild started the project of the Children Medicines Centre, with which they intend to build up, in cooperation with Gaslini Hospital and other best paediatrical institutions, a reference centre for the qualification of children medicines having the target of overcoming the actual difficulties.
- The 75% of all the medicines on the market does not have the approval of regulatory organizations to be used for newborns, children and teenagers.
- Therefore, paediatrists often find themselves to treat children with medicines which are not safe and efficacious for them..
- The modalities to grant protection to children as research subjects is a very delicate matter, as it comes out from directions and guidelines for children clinical studies and from the Declaration of Helsinki.
- The awareness of medicines use for children has been growing and growing during last years, taking to new laws and rules coming into force starting from the ‘90s.
- These regulatory initiatives are further encouraging to carry out children clinical studies, both in the process of production of new medicines and in the reassessment of those available for adults to be used for children, too.
- Trough the setting up of the MedChild Institute Pediatric Clinical Trial Office (PCTO), they aim to carry on or contribute to children clinical studies for all the development steps of a medicine, in compliance with the norms, granting safety, efficaciousness and efficiency.
