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 Second Survey “the Questionnaire Survey on Actual Situation of Established Conditions, Regulatory Actions Required for Changes and GMP Inspection”
Yoshio NAKAYAMA, Sonoko YAMAUCHI, Masatsugu KOBAYASHI, Kozue SHIMIZUME, Chisato HARADA, Akinobu NAKANISHI, Naoyuki MATSUMOTO, Yasuyo OZAKI, Yukihiro TARUI, Makoto FUJIKAWA, Hironori TAKAYAMA, Miyoko ONODA, Masayuki TAGAMI, Saiko MURATA, Yuji AWAMURA, Yuji KASHITANI
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Keywords: established conditions, regulatory submission, approval document
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2024 Volume 14 Issue 2 Pages 195-209

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Abstract

The Japan Pharmaceutical Manufacturers Association’s (JPMA) Regulatory Affairs Committee conducted the first survey about the actual situation of quality related Established Conditions, the submission category for changes, review periods and GMP inspection in Japan, US and EU in 2022 and reported differences in Japan, US and EU1) . We conducted the second survey to seek the cause of the differences in Japan, US and EU based on the result of the first survey and report differences in Established Conditions and systems of regulatory actions for changes in Japan, US and EU.

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© 2024 Society for Regulatory Science of Medical Products
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