The Good Laboratory Practice (GLP) Compliance Monitoring Program of Japan for Industrial Chemicals

Based on the OECD Principles of Good Laboratory Practice established by the OECD (Established in 1981, revised in 1997), the Good Laboratory Practice (GLP) has been established to ensure the reliability of various safety study results by confirming the compliance of each test facility with the GLP standards in terms of management, test equipment, study plans, internal inspection systems and quality assurance programs, and so forth.

Under the Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. (also known as the “Chemical Substances Control Law; CSCL”), a GLP system in conformity with the OECD-GLP (CSCL GLP) was introduced in March 1984. The study items subject to confirmation under the CSCL GLP by the Ministry of Economy, Trade and Industry are Biodegradation Test and Bioaccumulation Test, etc.

Procedures for receiving the confirmation of compliance with the CSCL GLP standards are set forth in the Handling of the Study Results for determination in the Evaluation of New Chemical Substances etc. (Director-General Notification by the Ministry of Health, Labor and Welfare, the Ministry of Economy, Trade and Industry and the Ministry of the Environment). Test facilities that intend to receive compliance confirmation need to submit an application to the Director-General of the competent bureau (the Director-General of the Manufacturing Industries Bureau of the Ministry of Economy, Trade and Industry in the case of Biodegradation Test and Bioaccumulation Test, etc.) and undergo a document review and an inspection as part of the confirmation process. Confirmation renewal is required every three years if the test facilities continue to receive compliance confirmation.
  For details on regulations pertaining to the GLP Compliance Monitoring Program for industrial chemicals, see the following documents (provisional English translations).

• [A-01] Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. (Excerpt) （PDF：707KB）
• [A-02] Ministerial Ordinance Specifying Items for Tests Pertaining to New Chemical Substances and Studies Pertaining to the Hazardous Properties of Priority Assessment Chemical Substances and Monitoring Chemical Substances （PDF：54KB）
• [A-03] Studies Specified Separately by the Minister of Health, Labour and Welfare, the Minister of　Economy, Trade and Industry and the Minister of the Environment Pursuant to the Provisions of Article 1, paragraph (2), Article 3, and Article 5, item (iv) of the Ministerial Order to Provide for Tests of New Chemical Substances and Items for Studies Related to Hazardous Properties of Priority Assessment Chemical Substances and Monitoring Chemical Substances （PDF：200KB）
• [A-04] Notice of the Good Laboratory Practice for test facilities conducting tests of New Chemical Substances etc. （PDF：553KB）
• [A-05] Handling of the Study Results for determination in the Evaluation of New Chemical Substances etc. （PDF：347KB）
• [A-06] National Public Service Act (Only article 100) （PDF：378KB）
• [A-07] Administrative Procedure Act (Only Chapter 3) （PDF：412KB）
• [A-08] Administrative Complaint Review Act （PDF：597KB）
• [A-09] A Comparison table of OECD GLP Principles and GLP for Industrial Chemicals in Japan （PDF：418KB）