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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

Others

Confidential Agreements

EC/JAPAN
  • Confidentiality Arrangement between the European Commission (EC) and the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan (PDF)
Health Canada/JAPAN
  • Confidentiality Arrangement between the Health Canada and the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan (PDF)
EU/JAPAN
  • Confidentiality Arrangement between the European Commission (EC) and the European Medicines Agency (EMEA) and the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan (PDF)
USFDA/JAPAN
  • Confidentiality Commitment Statement of Legal Authority and Commitment from the Pharmaceuticals and Medical Devices Agency (PMDA), Not to Publicly Disclose Non-Public Information Shared by the U.S. Food and Drug Administration, Department of Health and Human Services, Government of the United States of America (USFDA) (PDF)

Pharmaceuticals and Medical Devices Agency

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