Abstract
Clinical trials are essential for the evaluation of safety and efficacy of drugs in children. If a drug has been approved in adults without evaluation in children, pediatricians may start to use the drug ''off-labeled''. The Committee on Drugs of the Japan Pediatric Society has been actively involved in solving the off-label use of drugs in children in close corroboration with the Ministry of Health, Labour and Welfare (MHLW). MHLW has started the Study Group on Unapproved Drugs in 2005 and the Study Group on Pediatric Drug Therapy in 2006 to have necessary important pediatric drugs approved rapidly. But these two study groups works on the drugs which have I already been approved in the U.S. and/or E.U., and introduction of stronger regulatory and legal measures similar to the U.S. and the E.U. appears to be necessary for the elimination of approval lags in children. Stronger clinical trial infrastructure is also necessary. Pediatricians have been utilizing sponsor-investigator clinical trials to strengthen clinical trial infrastructure. The MHLW is currently funding 4 children's hospitals to establish a network for pediatric clinical trials. Academia, the regulatory agency and industries must work together for stronger regulatory framework and infrastructure for pediatric drug development in Japan.
