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