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 [1], 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.
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