Revision of PRECAUTIONS
PMDA Alert for Proper Use of Drugs
Pharmaceuticals and Medical Devices Safety Information
PMDA Updates
5th PMDA Training Seminar
  • Revisions of PRECAUTIONS
  • PMDA Alert for Proper Use of Drugs
  • Pharmaceuticals and Medical Devices Safety Information
  • PMDA Updates
  • 5th PMDA Training Seminar
1st PMDA Medical Devices Training Seminar SEMINAR HIGHLIGHT DAY 1 DAY 2 DAY 3 DAY 4 DAY 5
What's NewRSS FeedsBack number
->September 17, 2014 new
The 2nd CPC Subcommittee Meeting
->September 17, 2014 Updated
5th PMDA Training Seminar updated (Program Agenda)
->September 16, 2014
Publications: Updated
->September 16, 2014 new
Revisions of PRECAUTIONS : pregabalin and imatinib posted
->September 16, 2014 new
Medicines regulators to work together internationally to find innovative solutions to facilitate evaluation of and access to potential new medicines to counter Ebola outbreaks
->September 12, 2014 new
English translation of review report: Alabel/Alaglio
->September 11, 2014 new
PMDA Alert for Proper Use of Drugs: Adverse Events in Pregnant Women and Foetuses Associated with Use of ARBs and ACE Inhibitors
->September 10, 2014
MHLW Pharmaceuticals and Medical Devices Safety Information posted: No 314, FY2014
->September 8, 2014
[JP] Monterlukast Sodium, a new draft monograph for public review and comment posted
->September 5, 2014
The 1st Brazil-Japan Seminar on Regulations on Pharmaceuticals and Medical Devices
->September 4, 2014
New drugs approvals: FY 2013 (April 2013 - March 2014)
->September 2, 2014
[JP] Supplement II to the JP Sixteeth Edition (February 28, 2014, the MHLW Ministerial Notification No. 47) posted.
->September 1, 2014
The 2nd Thailand-Japan Symposium - New Drug Review, GMP Inspection, Pharmacovigilance -
->August 29, 2014
PMDA Updates (August, 2014) posted
->August 26, 2014
Executive Summary of Pharmaceuticals and Medical Devices Safety Information posted: No 315, FY2014
->August 22, 2014
PMDA Risk Communication: Imatinib and Pregabalin posted
->August 21, 2014
PMDA Medical Safety Information No.43
->August 18, 2014
Past Presentation: Files added
Publications: Updated

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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.

News and Reports
The Science Board

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

The Science Board The Science Board Subcommittees Outcome documents of the Science Board
Events / Symposia
Seminar
Past Presentations
Publications
Frequently Asked Questions (FAQ)
Services of PMDA
Drug and Medical Device Reviews

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

Post-marketing Safety

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