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PMDA Pharmaceuticals and Medidcal Devices Agency, Japan

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Services of PMDA

  • Drug and Medical Device Reviews
  • Outline
  • Approved Products
  • List of Approved Products
  • Review Reports of New Product Applications
  • Package Inserts Database (in Japanese)
  • Regulations and Procedures
  • Points to Be Considered by the Review Staff Involved in the Evaluation Process of New Drug (PDF)
  • Post-marketing Safety
  • Outline
  • Safety Information
  • MHLW Pharmaceuticals and Medical Devices Safety Information
  • PMDA Medical Safety Information
  • Other Information (in Japanese)
  • Regulations
  • Relief Services for Adverse Health Effects
  • Outline

International Programs

About PMDA

Approved Products

Safety Information

Regulations and Procedures

Publications

Past Symposiums

Past Presentations

Japanese Pharmacopoeia

Regulations and Procedures

  • Accreditation of Foreign Manufacturers
  • Master File System
  • GMP
  • QMS
  • Notifications
  • Ministerial Ordinances
  • Other Regulatory Actions
  • Application for Approval-Frequently Asked Questions (FAQ)
  • ICH Information (in Japanese)

Pharmaceuticals and Medical Devices Agency

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