Abstract
Off-label use in children is common throughout the world and a key issue. Activities resolving these issues have been stepped forward in the U.S. and EU since the 1990s. It have been tried various expedients to achieve the purpose. Because of need for facilitating the development of pediatric trials of therapies for HIV, eventually the following laws were legislated. These are referred to children in whole or in part.
U.S.: FDA Modernization Act (1997)
Best Pharmaceuticals for Children Act (2002)
Pediatric Research Equity Act (2003)
FDA Amendments Act of 2007
EU: Paediatric Regulation (2007)
These approaches would promote the pediatric clinical trials and the drug development in the U.S. and EU. We have to work together cooperatively with the U.S. and EU.
