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The following English translations of Japanese ministerial ordnances are intended to be a reference material to provide convenience for users. In the event of inconsistency between the Japanese originals and the translations, the former shall prevail.
Ministerial Ordinance on Good Laboratory Practice for Nonclinical Safety Studies of Drugs (PDF)- Ministerial Ordinance on Good Laboratory Practice for Nonclinical Safety Studies of Medical Devices (PDF)
- Ministerial Ordinance on Good Clinical Practice for Drugs (as amended, effective December 28, 2012) (PDF)
- Ministerial Ordinance on Good Clinical Practice for Medical Devices (PDF)
- Ministerial Ordinance on Standards for Quality Assurance for Drugs, Quasi-drugs, Cosmetics and Medical Devices (Tentative Translation :as of September 9,2005) [GQP] (PDF)
- Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Drugs and Quasi-drugs (Tentative Translation :as of September 9,2005) [GMP] (PDF)
- Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-vitro Diagnostic Reagents (Tentative Translation :as of September 9,2005) [QMS] (PDF)
- Regulations for Buildings and Facilities of Pharmacies, etc. (Tentative Translation :as of September 9,2005) (PDF)