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PMDA Pharmaceuticals and Medical Devices Agency, Japan

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About PMDA

Services of PMDA

  • Drug and Medical Device Reviews
  • Outline

Approved Products

  • List of Approved Products
  • Review Reports: Drugs
  • Review Reports: Medical Devices
  • Package Inserts (in Japanese)

Regulations and Procedures

  • Good Review Practice
  • Projects Across Multi-Offices in PMDA
  • Record of Consultations on Pharmacogenomics / Biomarkers
  • Post-marketing Safety
  • Outline

Safety Information

  • PMDA Risk Communications
  • The Yellow Letter / Blue Letter
  • Safety Information announced by MHLW
  • MHLW Pharmaceuticals and Medical Devices Safety Information
  • PMDA Medical Safety Information
  • PMDA Request for Proper Use of Drugs
  • Other Information (in Japanese)
  • MIHARI project
  • J-MACS
  • Regulations (in Japanese)
  • Relief Services for Adverse Health Effects
  • Outline

International Programs

The Science Board

Events / Symposia

Past Presentations

Publications

Japanese Pharmacopoeia

Japanese Pharmacopoeia

List of Approved Products

New Drugs

  • PDF FY 2012 (April - December) (PDF)
  • PDF FY 2011 (PDF)
  • PDF FY 2010 (PDF)
  • PDF FY 2009 (PDF)
  • PDF FY 2008 (PDF)
  • PDF FY 2007 (PDF)
  • PDF FY 2006 (PDF)
  • PDF FY 2005 (PDF)
  • PDF FY 2004 (PDF)

New & Improved Medical Devices

  • PDF FY 2012 New Medical Devices (April - September) (PDF)
  • PDF FY 2011 New & Improved (with Clinical Data) Medical Devices (PDF)
  • PDF FY 2010 New & Improved (with Clinical Data) Medical Devices (PDF)
  • PDF FY 2009 New & Improved (with Clinical Data) Medical Devices (PDF)
  • PDF FY 2008 New & Other (with Clinical Data) Medical Devices (PDF)
  • PDF FY 2007 New & Other (with Clinical Data) Medical Devices (PDF)
  • PDF FY 2006 New Medical Devices (PDF)
  • PDF FY 2005 New Medical Devices (PDF)
  • PDF FY 2004 New Medical Devices (PDF)

Pharmaceuticals and Medical Devices Agency

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