Medicines and children: children medicines qualification project
In 2000 an European Commission paper, Better Medicines for Children, had more specific targets, and in particular:
- increasing the availability of children pharmaceutical products, in different age groups;
- granting medicine watch as to long-period safety elements;
- avoiding clinical essays which might be repetitive supplying no further information;
- creating an excellence research in Europe in order to study children medicines setting up ad hoc scientific committees;
- granting a high ethical profile for the essays scheduled.
Such dutiful initiatives (representing a methodological reference point) did not have the results everybody hoped for, considering the very limited number of medicines IMEA approved in this period for paediatric use.
On the contrary, the American government intervened on the general issue of the lack for tested medicines, produced in the right way for children, imposing to the industry the rule of the compulsory double testing (on the adults, but on children, too) to introduce a new medicine in the market (The Pediatric Rule).
Between June 1998 and April 2002, 53 medicines were approved for children, and for 33 medicines new use instructions were given.
These regulatory initiatives are further encouraging the carrying out of children clinical studies, both during the production process of new medicines and the reassessment of those available for the adults as useful for children, too.
Following the example of a consortium of children centres working in USA carrying out clinical studies on children, the Paedriatic Pharmacology Research Units, they describe procedures and aims of a possible Paediatric Clinical Trial Office (PCTO) amongst the intervention proposals and projects of MEDCHILD.
Through a MEDCHILD Institute Paediatric Clinical Trial Office (PCTO), they would like to carry on or to contribute to clinical studies on children for all the development step of a medicine (from the 1st to the 4th one) in compliance with Good Clinical Practice/ICH regulations, granting safety, efficacy and efficiency.
The aim of the Medchild Institute PCTO is to set up a highly qualified service, in order to support the research, the carrying out of clinical studies on children, the management of research projects, and the development of new technologies for paediatrics.
Their aim is to set up a national and international children centres network, allowing to facilitate and promote the paedriatic labelling of new medicines, and the reassessment for children of therapies available for the adults, now used off-label on children.
With this children medicines qualification project, they want to encourage and strengthen the carrying out of cooperation researches among academics, regulatory agencies, pharmaceutical industry, and children specialists from an international point of view.
