EU Worksharing in the assessment of paediatric data
The absence of suitable information for many authorised medicinal products to treat conditions in children is an issue that has been a concern for some time. More than 50% of the medicines used to treat children in Europe has not been tested for use in children and are not authorised in children.
Recently, for medicines that are already in use for the adult population, more information has become available due to the initiative in the US to stimulate pharmaceutical industry to perform clinical studies in children. Also in the EU such an initiative has been taken by European Commission, but this new Paediatric Regulation will come into force only end 2006 or early 2007 and it will take time before more medicines for children will become available as a result of Paediatric Regulation. Furthermore, most of the future studies in children will be conducted with new medicinal products.
For medicinal products that are already on the market, the National Competent Authorities asked marketing authorisation holders to submit all data on the use of medicinal products in children. The National Competent Authorities are working together in the assessment of the paediatric data with the intention to agree on the same information and to share the Workload. This initiative is called the EU Work sharing procedure in the assessment of paediatric data. The main principle is that two Member States assess the data and prepare an assessment report for the other Member States. In an agreed timeframe other Member States can comment on the assessment reports. The conclusions from the assessment will be included in the medical product information and the assessment reports will be published to make more information available for Health professionals.
Although the newly submitted data are most of the time not sufficient to approve an indication for use in children, the available data can provide useful and important information for Health professionals who have to decide which medicines can be used to treat children.
For more details on the Work sharing procedure as agreed by Heads of Medicines Agencies(HMA) reference is made to the Best Practice Guide on the EU Work sharing procedure in the assessment of paediatric data.
This Work sharing procedure is an ongoing project and new assessment reports will added when the procedures are finalised.