NATIONAL PROFILE on Chemicals Management - UNITAR

Chapter 9Technological infrastructure9 1 Overview of the research infrastructure● National Institute of Health Sciences (NIHS)The National Institute of Health Sciences (NIHS) undertakes tests, research and study tocorrectly assess the quality, safety and efficacy of pharmaceuticals, foodstuffs and otherchemical substances which are found in the living environment. The results are mainlyreflected in the administration by the Ministry of Health, Labour and Welfare (MHLW),and serve to maintain and improve the health of people and their living environment.Furthermore, it reviews the applications for approvals, re-examintions and reevaluationsof production and import of pharmaceuticals and medical devices, and theexamination necessary for re-examination and re-evaluation. For this purpose, thePharmaceuticals and Medical Devices Evaluation Centre was established in FY1997 andhas taken measures for a prompt and exact reviews.● National Institute of Advanced Industrial Science and Technology (AIST)While developing a comprehensive method for the risk assessment of chemical substances,the National Institute of Advanced Industrial Science and Technology (AIST) carries outindividual assessment of the chemicals such as Designated Chemicals under the LawConcerning Reporting, etc. of Releases to the Environment of Specific ChemicalSubstances and Promoting Improvements in Their Management.● National Institute for Environmental Studies (NIES)The National Institute for Environmental Studies (NIES) undertakes study and researchand the collection, compilation and provision of domestic and overseas data relating to thepreservation of the environment. The results of this research are widely issued in so manypublications including the Institute’s own circulations to academic journals.● Facilities conforming to the criteria of GLP for chemical substancesRegarding notification, etc. stipulated in the Law Concerning the Evaluation of ChemicalSubstances and Regulation of Their Manufacture, etc., in principle, the governmentestablishes a condition for acceptance of data to conduct tests based on the OECD’s testingguideline at the facilities conforming to the criteria of OECD/GLP (Good LaboratoryPractice). In order to ensure the reliability of data, the Ministry of Health, Labour andWelfare (MHLW) (for toxicity, etc.) and the Ministry of Economy, Trade and Industry(METI) (for bio-degradability, bio-accumulation, etc.) conduct inspections of testingfacilities based on the OECD’s Guidance for the conduct of Laboratory Inspection andStudy Audits. Furthermore, there are regulations regarding the mutual acceptance of data,etc. complying with the OECD/GLP standard in the Agreement on Mutual Recognitionbetween Japan and European Community.60