Japan MHLW Ordinance 21 Good Laboratory Practice for Nonclinical Safety Studies of Drugs, 6/08
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Japan’s Ministerial Ordinance on Good Laboratory Practice for Nonclinical Safety Studies of Drugs was published to provide the GLP standards for conducting nonclinical safety studies of drugs at test facilities or test sites using test systems and data.
This 1997 ordinance (last amended in 2008) was made available in English in 2012.
There are expectations for handling raw data, records and reports throughout the ordinance.
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OECD The Application of GLP Principles to Computerised Systems DRAFT, 9/14
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