The European Regulation on medicines for paediatric use

摘要: The European Regulation on medicines for paediatric use entered into force 26 January 2007. It marks a radical change in the Union terms of encouraging development age groups and improving availability information children. How will new Paediatric achieve this? For first time, companies be required to study population develop age-appropriate formulations. As reward or incentive conducting these studies, entitled extensions patent protection market exclusivity. establishes clinical trials network programme off-patent medicines, latter funded through Community Framework Programmes. A Committee, based at Medicines Agency, responsible agreeing investigation plan (PIP) with companies. This describe other measures necessary investigate particular medicine population. database, partly accessible public, hold details results all conducted line PIPs. All authorised identified by symbol package label. After 5 years, there stocktake view making changes if necessary.