Affiliations: Division of Clinical Research, National Children's
Hospital, National Centre for Child Health and Development, Tokyo, Japan.
Abstract: The Ministry of Health, Labour and Welfare (MHLW) and related
government agencies have been implementing strategies to facilitate clinical
trials in the last few years , and the infrastructure for paediatric
clinical trials is being strengthened. The revision of the Pharmaceutical
Affairs Law (PAL) in 2002 has enabled physicians to conduct
sponsor-investigator trials in Japan. There have been 9 protocols for 6 drugs
funded by the MHLW in children completed or ongoing as of August, 2009. The
National Centre for Child Health and Development (NCCHD) has been involved in 7
of these protocols. Of these 7 protocols, NCCHD has been involved in project
management for 5 protocols.