Pharmaceutical Affairs Law

  • 시행중
  • Level 1
  • Standard
  • 2014-11-25
  • 2014-11-25
  • Ministry of Health, Labour and Welfare (MHLW)

Pharmaceutical Affairs Law of Japan is a law regulating the manufacturing, importation, and sale of drugs and medical devices. It was originally passed in 1960. On May 24th 2013, the Government Cabinet approved a revision of Pharmaceutical Affairs Law to simplify the approval process for medical devices and regenerative medicine products, the safety of regenerative medicine using iPS cells. Some amendments have taken into effect on November 25, 2014. 

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