Better medicines for children
In September 2004, the European Commission issued a proposal for a regulation on medicinal products for paediatric use. The EU Regulation (EC) No 1902/2006 on paediatric medicines was adopted by the European Parliament and the Council on 27 December 2006. The new European Regulation on Paediatric medicines entered into force on 26 January 2007. Eurordis responded to the initial proposal with a position paper, published in January 2005. The paper welcomed and supported the overall objective of the proposal. Eurordis intervened at each stage of the regulatory decision-making process with the publication of position papers, comments, and letters to authorities between 2000 and 2006.
Children in general, as they are still developing, respond differently to medicines than adults do. About 50% of all people affected by rare disorders are less than 19 years old. Hence the importance to rare disease patients of the establishment of a Regulation on Medicinal Products for Paediatric Use.
For more information:
- Summary of the Legislation