PMDA Risk Communications
Pharmaceuticals and Medical Devices Safety Information
PMDA Updates
Sovriad Capsules 100mg and Hyperbilirubinaemia
Revision of PRECAUTIONS
5th PMDA Training Seminar
2nd PMDA Medical Devices Training Seminar
PMDA Updates
  • PMDA Risk Communications
  • Pharmaceuticals and Medical Devices Safety Information
  • PMDA Updates
  • Dear Healthcare Professional Letter of Rapid Safety Communication
  • Revisions of PRECAUTIONS
  • 5th PMDA Training Seminar
  • 2nd PMDA Medical Devices Training Seminar
5th PMDA Training Seminar SEMINAR HIGHLIGHT DAY 1 DAY 2 DAY 3 DAY 4 DAY 5
What's NewRSS FeedsBack number
->October 31, 2014 new
PMDA Risk Communication: galantamine posted
->October 31, 2014 new
MHLW Pharmaceuticals and Medical Devices Safety Information posted: No 316, FY2014
->October 30, 2014 new
PMDA Updates (October, 2014) posted
->October 28, 2014 new
Executive Summary of Pharmaceuticals and Medical Devices Safety Information posted: No 317, FY2014
->October 28, 2014 new
BLUE LETTER: Sovriad Capsules (Simeprevir Sodium) 100 mg and Hyperbilirubinaemia, Case Report
->October 24, 2014
BLUE LETTER: Sovriad Capsules (Simeprevir Sodium) 100 mg and Hyperbilirubinaemia
->October 23, 2014 updated
PMDA Training Seminar
->October 22, 2014
Revisions of PRECAUTIONS: enzalutamide, teneligliptin, vancomycin, and acetaminophen posted
->October 20, 2014
New & Improved (with Clinical Data) Medical Devices approvals: FY 2013
->October 16, 2014
PMDA Medical Safety Information No.44
->October 16, 2014
5th PMDA Training Seminar: DAY 4 & DAY 5 uploaded
->October 8, 2014
The 1st Meeting of the Subcommittee on Placebo-controlled Studies
->October 7, 2014
New Medical Devices approvals: FY 2013
->October 1, 2014
The 2nd PMDA Medical Devices Training Seminar
->October 1, 2014
Executive Summary of Pharmaceuticals and Medical Devices Safety Information posted: No 316, FY2014
->October 1, 2014
MHLW Pharmaceuticals and Medical Devices Safety Information posted: No 315, FY2014
->September 30, 2014
2nd Joint Conference of Taiwan and Japan on Medical Products Regulation
->September 30, 2014
PMDA Updates (September, 2014) posted
->September 26, 2014
PMDA Risk Communication: enzalutamide, teneligliptin, and vancomycin posted
->September 25, 2014
English translation of review report: Kadcyla
->September 17, 2014
The 2nd CPC Subcommittee Meeting
->September 17, 2014 Updated
5th PMDA Training Seminar updated (Program Agenda)
->September 16, 2014
Publications: Updated
->September 16, 2014
Revisions of PRECAUTIONS : pregabalin and imatinib posted
->September 16, 2014
Medicines regulators to work together internationally to find innovative solutions to facilitate evaluation of and access to potential new medicines to counter Ebola outbreaks

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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