Revision of PRECAUTIONS
Pharmaceuticals and Medical Devices Safety Information
PMDA Risk Communications
2nd PMDA Medical Devices Training Seminar
PMDA Updates
5th PMDA Training Seminar
PMDA Updates
  • Revisions of PRECAUTIONS
  • Pharmaceuticals and Medical Devices Safety Information
  • PMDA Risk Communications
  • 2nd PMDA Medical Devices Training Seminar
  • PMDA Updates
  • 5th PMDA Training Seminar
5th PMDA Training Seminar SEMINAR HIGHLIGHT DAY 1 DAY 2 DAY 3 DAY 4 DAY 5
What's NewRSS FeedsBack number
->December 22, 2014 new
Revisions of PRECAUTIONS: cabazitaxel posted
->December 17, 2014 new
Administrative Notice, Q&A on Adverse Drug Reaction and Malfunction Reports of Combination Products
->December 17, 2014 new
MHLW Pharmaceuticals and Medical Devices Safety Information posted: No 317, FY2014
->December 16, 2014
Publications: Updated
->December 10, 2014
PMDA Medical Safety Information No.45
->December 5, 2014
PMDA Risk Communication: mumps virus vaccine, linagliptin, sodium-glucose co-transporter 2 inhibitors, simeprevir, amoxicillin, and levetiracetam posted
->December 5, 2014
PFSB/CND Notification No.1024-15, Handling of Marketing Application for Combination Products
->November 28, 2014
PMDA Updates (November, 2014) posted
->November 28, 2014
[JP] Pharmacopoeial Discussion Group (PDG) meeting was held in Strasbourg, France on November 12 and 13, 2014 (Press Release, Meeting Highlights)
->November 28, 2014 updated
[JP] Pharmacopoeial Discussion Group (PDG) State of Work updated
->November 28, 2014 updated
[JP] Timetable for implementation of signed documents by Pharamacopoeial Discussion Group (PDG) updated
->November 25, 2014
Executive Summary of Pharmaceuticals and Medical Devices Safety Information No 318, FY2014, and 3 case reports of Sovriad posted
->November 20, 2014
PFSB/SD Notification No. 0929-2, Guideline on Revision of Precautions and other information
->November 20, 2014
Revisions of PRECAUTIONS : galantamine posted
->November 19, 2014
Investigation results: SOVRIAD (simeprevir sodium)
->November 17, 2014
English translation of review report: Stelara

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International Programs

Implementation of PMDA International Strategic Plan through international regulatory harmonization, bilateral relationship, effective communication with relevant external parties, etc.

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Framework to explore appropriate methods to evaluate medical products using advanced science and technology while exchanging opinions among academia and reviewers.

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Drug and Medical Device Reviews

Scientific reviews and conformity audits of marketing authorization applications of drugs and medical devices, clinical trial consultations

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Collection, analysis and dissemination of information related to the quality, efficacy and safety of pharmaceuticals and medical devices

Relief Services for Adverse Health Effects

Providing financial assistance for individuals affected by adverse drug reactions or infections from biological products