![]() ![]() The evaluation found that the Paediatric Regulation has fostered the development and availability of medicines for children. It has redirected private and public investment towards previously neglected areas through incentives, obligations and rewards. The European Commission has conducted a comprehensive review of the strengths and weaknesses of the EU regulatory framework governing paediatric medicines. The PDCO replaced the Agency's previous Paediatric Working Group. The Committee's main role is to determine the studies that companies must carry out on children as part of paediatric investigation plans (PIPs). Its main impact was the establishment of the Paediatric Committee (PDCO), which is responsible for coordinating the Agency's work on medicines for children. ![]() The Regulation dramatically changed the regulatory environment for paediatric medicines in Europe. It aims to achieve this without subjecting children to unnecessary trials or delaying the authorisation of medicines for use in adults. The Regulation aims to ensure that medicines for use in children are of high quality, ethically researched and authorised appropriately and improving the availability of information on the use of medicines for children. Its objective is to improve the health of children in Europe by facilitating the development and availability of medicines for children aged 0 to 17 years. The Paediatric Regulation came into force in the European Union (EU) on 26 January 2007.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |