Morikawa Kaoru, Yamamoto Michiko, Nakano Tatsuya, Kasuga Fumiko, Yamamoto Miyako
Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku. 2003(121):1-11.
Recent issues on BSE(Bovine Spongiform Encephalopathy) and health hazards caused by adverse reactions of medical drugs, have strongly emphasized the necessity for safety measures to secure public health. These issues have been attributed to the delay to obtain overseas information on safety and regulation, and the lack of an adequate system for acquirement and assessment of such information. In order to develop a system where domestic and international safety information is collected, analyzed, assessed and presented both scientifically and systematically, the Division of Chem-Bio Informatics of the National Institute of Health Sciences was reorganized to the Division of Safety Information on Drug, Food and Chemicals in April, 2003. Collection and evaluation of safety information on medical drugs, food and chemical substances is now centralized at the Division, which consists of 5 sections, the first, second and third sections being newly established. The first section assesses information on medical drugs, the second section deals with food microorganisms, and the third section focuses on chemicals in food. The fourth and fifth sections retain their previous functions, namely, chemical safety information research and information network infrastructure support within the institute, respectively. The purpose of this paper is to describe how we will manage safety information on drug, food and chemicals, focusing on the role of the three new sections.
近期有关疯牛病（牛海绵状脑病）以及药物不良反应所引发的健康危害问题，强烈凸显了采取安全措施以保障公众健康的必要性。这些问题归因于获取海外安全与监管信息的延迟，以及缺乏一个足够的此类信息获取与评估体系。为了构建一个能科学且系统地收集、分析、评估并呈现国内和国际安全信息的体系，国立卫生科学研究所的化学生物信息学部于2003年4月重组为药品、食品及化学品安全信息部。药品、食品和化学物质安全信息的收集与评估如今集中于该部门，该部门由5个科室组成，其中第一、第二和第三科室是新设立的。第一科室评估药品信息，第二科室处理食品微生物，第三科室专注于食品中的化学物质。第四和第五科室保留其先前的职能，即分别进行化学安全信息研究以及为研究所内的信息网络基础设施提供支持。本文旨在描述我们将如何管理药品、食品和化学品的安全信息，重点关注三个新科室的作用。
