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PMDA Pharmaceuticals and Medidcal Devices Agency, Japan

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GMP

Announcement from Office of Compliance and Standards, PMDA

  • Documents required by PMDA for the Application of GMP Compliance Inspection (PDF)
  • [Form3] Outline of Drug Manufacturing Site (Foreign Manufacturing Site) (WORD)

Overview Guidance of GMP Compliance Inspection for Foreign Manufacturers

  • GMP Compliance Inspection concerning Pharmaceuticals (including APIs) (PDF)
  • Documents to be submitted for GMP Compliance Inspection (PDF)

Ministerial Ordinance on GMP

  • Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Drugs and Quasi-drugs (Tentative Translation :as of September 9,2005) [GMP] (PDF)

Pharmaceuticals and Medical Devices Agency

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan