Japan MHLW
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Japan MHLW Ordinance 28 Good Clinical Practice for Drugs, 12/12
Japan’s Ministerial Ordinance provides GCP standards to ensure the quality of clinical trials and the reliability of clinical trial data for drugs.
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Japan Q&A on GMP Guideline on Managment of Computerized Systems, 10/10
An independent group produced this translation of the Q&A document that accompanies the 2010 Japaneseﾠ Guideline on Management of Computerized Systems.
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Japan GMP Guideline on Management of Computerized Systems, 10/10
English translation of the 2010 Japanese Guideline on Management of Computerized Systems for Marketing Authorization Holders and Drug Manufacturers.
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Japan MHLW Ordinance 36 Good Clinical Practice for Medical Devices, 3/09
Japan’s ordinance on Medical Device GCP provides standards to ensure the scientific quality of clinical trials and the reliability of clinical trial data.
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Japan MHLW Ordinance 37 Good Laboratory Practice for Nonclinical Safety Studies for Medical Devices, 6/08
Japan’s 2008 Ministerial Ordinance provides GLP standards for conducting nonclinical safety studies of medical devices at test facilities or test sites.
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Japan MHLW Ordinance 21 Good Laboratory Practice for Nonclinical Safety Studies of Drugs, 6/08
Japan’s 2008 Ministerial Ordinance provides GLP standards for conducting nonclinical safety studies of drugs at test facilities or test sites.
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Japan MHLW Ordinance 179 2004 Manufacturing Control and Quality Control for Drugs, 12/04
This Ministerial Ordinance was published in 2004, and has requirements records and data throughout the document.
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Japan MHLW Ordinance 169 2004 Manufacturing Control and Quality Control for Medical Devices, 12/04
Japan’s Ministerial Ordinance for Manufacturing Control and Quality Control Standards for medical devices and in-vitro diagnostic reagents was published in 2004.
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Japan MHLW Ordinance 136 2004 Quality Assurance for Drugs, Cosmetics, and Medical Devices, 9/04
Japan’s 2004 Ministerial Ordinance on Standards for Quality Assurance for drugs, quasi-drugs, cosmetics, and medical devices. Records requirements throughout.
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