Regulatory Science of Medical Products
Online ISSN : 2189-0447
Print ISSN : 2185-7113
ISSN-L : 2185-7113
Discussion Related to Approval Document and Regulatory Actions for Changes Based on the Results of the Third Survey “the Questionnaire Survey on Actual Situation of Established Conditions, Regulatory Actions Required for Changes and GMP Inspection”
Kozue SHIMIZUMEYoshio NAKAYAMASonoko YAMAUCHIMasatsugu KOBAYASHIAkinobu NAKANISHIMaki MASUYAMAYasuyo OZAKIYukihiro TARUIMakoto FUJIKAWAKoji NAKAMURAYuji KASHITANI
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2025 Volume 15 Issue 3 Pages 183-194

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Abstract

 The Japan Pharmaceutical Manufacturers Association’s Regulatory Affairs Committee has reported on the differences between Japan, the United States, and Europe with regard to the description of quality-related approval document, categories of approval item change procedures and review periods, and the operation of GMP investigations. Since discussions have started in Japan toward the realization of a risk-based change management system for international harmonization, we report on the current understanding of “risk-based change management” as the third survey.

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© 2025 Society for Regulatory Science of Medical Products
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