Current situation and critical points for paediatric research in Japan

Article type: Research Article

Authors: Nakamura, Hidefumi

Affiliations: Division of Clinical Research, National Children's Hospital, National Centre for Child Health and Development, Tokyo, Japan. E-mail: nakamura-hd@ncchd.go.jp

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.

Keywords: Pharmaceutical Affairs Law, Japan, NCCHD, incentives, paediatrics

DOI: 10.3233/PPL-2010-0282

Journal: Pharmaceuticals, Policy and Law, vol. 12, no. 1-2, pp. 117-121, 2010