Regulatory outline Japan

In 1996 the ICH, representing FDA, EU, and Japanese regulatory authorities, published GCP expeetations that ineluded factors affecting computer validation. The FDA, EU, and Japan have all adopted the ICH GCPs. Three key principles that are relevant to computer applications are outlined ... 

The current regulatory position of the three regions has been outlined in the notes for The Guidance for the Mutual Use of Foreign Data in the EC, Japan, and US, Part 1. The ADME concern has been well defined and quantified in separate reports. 

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