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--> Skip to content small default large Home Inquiries---> National Institute of Public Health National Institute of Public Health Menu ホーム 概要 組織 研修内容 情報提供 各種施設 刊行物 アクセス リンク サイトマップ お問い合わせ ----> 小さく 標準 大きく -----> HOMEOverviewOrganizationTrainingResearch AchievementsFacilitiesLibraryJournalAccess Journal of the National Institute of Public Health Vol.71 No.2 -- .entry-header --> Home > Journal of the National Institute of Public Health > Back number > Vol.71　No.2 Journal of the National Institute of Public Health Print edition : ISSN 1347-6459 Online edition : ISSN 2432-0722 Vol.71 No.2 （May 2022） Topics：Revised GMP Ministerial Ordinance and current topics on regulations of pharmaceuticals and medical devices in Japan Preface TERADA Hiroshi Revised GMP Ministerial Ordinance and current topics on regulations of pharmaceuticals and medical devices in Japan（1126KB）　Page 113-114 Topics TANAKA Ryoichi Amendments to GMP-related laws and regulations and the efforts of the Kyoto Prefectural Pharmaceutical Affairs Support Center〈Note〉（1926KB）　Page 115-128 KOYAMA Yasuto A perspective on quality assurance and GMP for the manufacture of medicinal products: from the viewpoint of implementation of pharmaceutical quality system based on GMP Ministerial Ordinance〈Review〉（1757KB）　Page 129-139 TOBITA Yuki, YAMAMOTO Gou, KUDOU Toshiaki, YUMOTO Takafumi Recent non-conformity with PMD Act at pharmaceutical manufacturing sites and preventing measures for reoccurrence of such non-conformity〈Review〉（1903KB）　Page 140-146 MISHIMA Katsuhiko Points of the revised GMP Ministerial Ordinance with reference to its expected roles in prevention of recently arising pharmaceutical quality issues〈Review〉（1815KB）　Page 147-155 MURAKAMI Madoka Overview of medical device regulations and recent updates〈Review〉（1240KB）　Page 156-162 TERADA Hiroshi, BEKKI Kanae, YAMAGUCHI Ichiro Education and training for GMP inspectors in Japan to ensure international harmonization of GMP inspection〈Review〉（1205KB）　Page 163-174 Original HEMMI Osamu, ISHIKAWA Midori, YOKOYAMA Tetsuji The associations between secular changes in smoking rate and those in cause-specific death rates among prefectures in Japan（1797KB）　Page 175-183 Educational Reports　Page 184-188 保健医療科学保健医療科学Current numberBack numberInstructions for authors / General guide to JNIPH(pdf)   National Institute of Public HealthAddress: 2-3-6 Minami, Wako-shi, Saitama 351-0197 JapanTEL:+81-48-458-6111 FAX:+81-48-469-1573 National Institute of Public Health Website Terms of Use Accessibility Privacy Policy Copyright(C)National Institute of Public Health.All Rights Reserved. Proudly powered by WordPress ------->