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A list of GLP-related Japanese regulations for industrial chemicals

A list of GLP-related Japanese regulations
for industrial chemicals

Initially uploaded: January, 2023
Last updated: September, 2023

Disclaimer

English translations that correspond to the documents included in the list below, to which you can jump by clicking the title of the documents,
　（ⅰ）are provisional,
　（ⅱ）are not necessarily based on the latest versions of the original Japanese documents at the time of upload, and
　（ⅲ）will not necessarily be updated without delay after future revision of original Japanese documents.

Hence, if discrepancies exist between the English translations and the latest original Japanese documents, then the latter precedes.

Update log

2023-09-04 　Published translation B-02.

2023-08-07　Updated A-05 with Form 1-3.

List of regulations

A：Legislation and Reference common to all three areas
i.e. (i) human health, (ii) biodegradation/bioaccumulation and (iii) environmental effects.

No	Category	Title	the legislation ^1 / the date of the last revision ^2 / date of enforcement ^*3	Remarks	Title in Japanese
A-01	Law	Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. (Act No. 117 of October 16, 1973)［588KB］	by the Act No. 53 of 2017	Partly modified	化学物質の審査及び製造等の規制に関する法律
A-02	Ministerial ordinance	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［49KB］	by Ministerial Ordinance No. 4, Ministry of Health, Labour and Welfare, Ministry of Economy, Trade and Industry, and Ministry of the Environment / March 30, 2018 / April 1, 2018		新規化学物質に係る試験並びに優先評価化学物質及び監視化学物質に係る有害性の調査の項目等を定める省令
A-03	Public notice	Tests which Minister for Health, Labour and Welfare, Minister for Economy, Trade and Industry and Minister for the Environment designate separately, based on prescriptions of Article 1 Item 2, Article 3 and Article 5 Item 4［197KB］	by Public notification No. 6, Ministry of Health, Labour and Welfare, Ministry of Economy, Trade and Industry, and Ministry of the Environment / March 30, 2018 / April 1, 2018		新規化学物質に係る試験並びに優先評価化学物質及び監視化学物質に係る有害性の調査の項目等を定める省令第一条第二項、第三条及び第五条第四号の規定により厚生労働大臣、経済産業大臣及び環境大臣が別に定める試験
A-04	Director- General notification	Notice of the Good Laboratory Practice for test facilities conducting tests of New Chemical Substances etc. (March 31, 2011, PFSB Notification 0331 No.8, MIB Notification 23.03.29 No.6, EHD Notification No.110331010)［548KB］			新規化学物質等に係る試験を実施する試験施設に関する基準について
A-05	Director- General notification	Handling of the Study Results for determination in the Evaluation of New Chemical Substances etc. (PFSB Notification 0331 No.9 Mar. 31, 2011, MIB Notification No.7 Mar. 29, 2011, EHPPMD notification No.110331011)［390KB］	Dec. 25, 2020		新規化学物質の審査等に際して判定の資料とする試験成績の取扱いについて
A-06	Law	National Public Service Act (Act No. 120 of October 21, 1947)［378KB］	by Act No.68 / Jun. 17, 2022 / Jun. 17, 2022	Only Article 100	国家公務員法（第100条抜粋）
A-07	Law	The Administrative Procedure Act (Act No. 88 of November 12, 1993)［408KB］	by Act No. 70 of June 13, 2014	Only Chapter 3	行政手続法（第3章抜粋）
A-08	Law	The Administrative Complaint Review Act (Act No. 68 of June 13, 2014)［583KB］			行政不服審査法
A-09	Reference	A Comparison table of OECD GLP Principles and GLP for Industrial Chemicals in Japan［941KB］			OECD-GLP原則と化審法GLPの比較対比表

^*1the legislation by which original Japanese document on which English translation was made was revised
^*2the date of the last revision of the original Japanese document at the time when the English translation was made
^*3date of enforcement of the original Japanese legislation which is used for English translation

B：Notification and Guidelines specific to human health (Issued by MHLW)

No	Category	Title	Date of issue	Remarks	Title in Japanese
B-01	Director- General notification	Guidelines for the conduct of laboratory inspections under the Principles for test facilities conducting tests of New Chemical Substances, etc.［1.2MB］	December 26, 2013	Notification 0229 No. 2, dated February 29, 2012 was replaced by this B-01	新規化学物質等に係る試験を実施する試験施設に関する基準に基づく査察実施要領について
B-02	Director notification	Considerations for the "Guidelines for the inspection of GLP for Chemical Substances" (Human health effect)［912KB］	August 12, 2022	Revised by PSPE Notification 0901 No.1 dated September 1, 2023	「化学物質ＧＬＰ査察実施要領」の留意事項（人健康影響）について
B-03	Guidelines	Guidelines on the Preparation of Documents for Obtaining Certification of GLP Compliance［470KB］	March 31, 2004		化学物質ＧＬＰ適合確認に係る資料作成要領