The Paediatric Regulation came into force in the European Union (EU) on 26 January 2007. Its objective is to improve the health of children in Europe by facilitating the development and availability of medicines for children between birth and the age of 18 years.
The Regulation aims to: ensure that medicines for use in children are of high quality, ethically researched and authorised appropriately; and improve the availability of information on the use of medicines for children. It aims to achieve this without subjecting children to unnecessary trials or delaying the authorisation of medicines for use in adults…
