The EU Paediatric Regulation

| 01 March 2008

The Paediatric Regulation1 was adopted in December 2006 by the European Parliament and the Council of Europe with the goals of improving the availability of paediatric medicines; increasing high-quality, ethical paediatric research; and increasing information about the use of medicines in the paediatric population without delaying marketing authorisation in adults or conducting unnecessary trials in children. The regulation is the end result of proposals made to encourage companies to develop medicines for children and follows extensive consultation with stakeholders on the first legislative texts.2,3 This article summarizes the initiatives taken by the European Medicines Agency (EMEA) to implement this regulation, which came into force on 26 January 2007.


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