PMDA Updates
Revision of PRECAUTIONS
XEPLION Aqueous Suspension for IM injection
Pharmaceuticals and Medical Devices Safety Information
PMDA Risk Communications
1st PMDA Medical Devices Training Seminar
  • PMDA Updates
  • Revisions of PRECAUTIONS
  • Dear Healthcare Professional Letter of Rapid Safety Communication
  • Pharmaceuticals and Medical Devices Safety Information
  • PMDA Risk Communications
  • 1st PMDA Medical Devices 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
->April 24, 2014 New
PMDA Updates (April, 2014) posted
->April 24, 2014 New
Revisions of PRECAUTIONS: Pentamidine Isetionate
->April 24, 2014 New
[JP] Schedule of JP publication updated
[JP] Preface of Supplement II to Japanese Pharmacopoeia Sixteenth Edition (provisional English translation) posted
->April 24, 2014 New
[JP] PDG Stage 4 Draft; Peptide Mapping, Rev. 1 posted
->April 22, 2014 New
XEPLION (Paliperidone Palmitate) BLUE LETTER Case Report
->April 21, 2014 New
XEPLION (Paliperidone Palmitate) BLUE LETTER
->April 16, 2014 New
PMDA Training Seminar
->April 16, 2014 New
About the extension of the EMA-FDA pilot program of QbD.
->April 10, 2014
New drugs approvals: April - December 2013
->April 10, 2014
MHLW Pharmaceuticals and Medical Devices Safety Information posted: No 310, 2013
->Apr 4, 2014
PMDA Risk Communication: information on Keishibukuryogan, Clemastine Fumarate, and Pentamidine Isetionate posted
->March 26, 2014
Executive Summary of Pharmaceuticals and Medical Devices Safety Information posted: No 311, 2013
->March 26, 2014
PMDA Medical Safety Information No.39
->March 26, 2014 Updated
PMDA Risk Communication updated
->March 25, 2014
PMDA Medical Safety Information No.38
->March 25, 2014
[JP] Errata for Japanese Pharmacopoeia Sixteenth Edition updated
[JP] Errata for Supplement I to Japanese Pharamcopoeia Sixteenth Edition posted
->March 24, 2014
PMDA Updates (March, 2014) posted
->March 19, 2014
English translation of review report: Stivarga
->March 19, 2014
[JP] Supplement II to the Japanese Pharmacopoeia Sixteenth Edition "Contents" (English) updated
[JP] Provisional English translation of MHLW Ministerial Notification No. 47 posted
->March 17, 2014
English translation of review report: Vyndaqel
->March 14, 2014
Summary of International Activities uploaded
->March 14, 2014
The 6th Science Committee (parent committee) Meeting
->March 13, 2014
Publications: Updated
->March 13, 2014
English translation of review report: Lyxumia
->March 13, 2014
English translation of review report: Xalkori
->March 7, 2014
1st PMDA Medical Devices Training Seminar: DAY 5 uploaded
->March 7, 2014 Updated
1st PMDA Medical Devices Training Seminar: DAY 4 updated
->March 6, 2014 Updated
1st PMDA Medical Devices Training Seminar: DAY 3 updated
->March 5, 2014
MHLW Pharmaceuticals and Medical Devices Safety Information posted: No 309, 2013
->March 4, 2014
1st PMDA Medical Devices Training Seminar: DAY 2 uploaded
->March 3, 2014
1st PMDA Medical Devices Training Seminar: DAY 1 uploaded
->March 3, 2014
[JP] Supplement II to the Japanese Pharmacopoeia Sixteenth Edition "Contents" (English) posted.

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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

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