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- W4240642783 abstract "This chapter describes the brief history and recent development of Japanese post-approval safety procedures. Two systems of “re-evaluation” and “re-examination” were introduced in the 1970s. The “re-examination” system involves a reassessment of all new drugs normally after 8 years following the first approval where the submission of the findings in the “drug use investigation” (DUI) is normally requisite. Though the DUI, a stereotyped study without a comparator where thousands of patients prescribed a new product are followed usually for 6 months, still prevails, a new trend is also emerging. The number of studies on the safety of approved drugs using the legitimate pharmacoepidemiology design is gradually increasing and a large claims database covering the whole nation, called the national database, is now ready to use for epidemiological studies. The chapter also describes the risk minimization plans currently operated in Japan." @default.
- W4240642783 created "2022-05-12" @default.
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- W4240642783 date "2014-04-01" @default.
- W4240642783 modified "2023-10-01" @default.
- W4240642783 title "Pharmacovigilance and Risk Management in Japan" @default.
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- W4240642783 doi "https://doi.org/10.1002/9781118820186.ch15a" @default.
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