Publication of Risk Management Plans
GMP Regulations, Guidelines, etc. and Globalization Efforts
PMDA Risk Communications
  • Publication of Risk Management Plans
  • GMP Regulations, Guidelines, etc. and Globalization Efforts
  • PMDA Risk Communications
What's NewRSS FeedsBack number
->June 19, 2013 New
New drug approvals: Fiscal year 2012 (April 2012 – March 2013)
->June 17, 2013 New
The 4th Medical Devices Subcommittee was held
->June 14, 2013 New
PMDA Risk Communication: Drug safety information which has come under review by the MHLW/PMDA （Tolvaptan, Paliperidone, Sulbactam / Ampicillin, Peramivir, Itraconazole, Albendazole, Sitafloxacin, Golimumab）posted
->June 13, 2013 New
Press release announced by MHLW: Exemption of the EU's regulatory control applicable to APIs exported from Japan to the European Union posted
->June 10, 2013 New
Safety information announced by MHLW: Publication of Risk Management Plans posted
->June 7, 2013 New
Past Presentation: Files added
->June 4, 2013 Updated
PMDA Risk Communication updated
->June 4, 2013
Recruitment Information for Native English Advisor
->May 31, 2013
The partial revision of JP 16th edition was notified (May 31, 2013, the MHLW Ministerial Notification No.190). The revised general test <6.02> Uniformity of Dosage Units and the revised monograph Gelatin are officially published.
->May 31, 2013
Executive Summary of Pharmaceuticals and Medical Devices Safety Information posted: No 301, 2013
->May 29, 2013
English translation of review report: Bridion
->May 28, 2013 Updated
Dear Haelthcare professional letter of rapid safety communication (Igratimod) updated
->May 28, 2013
PMDA Updates (May, 2013) posted
->May 28, 2013
English translation of review report: Poteligeo
->May 27, 2013
Road map for the PMDA International Vision published
->May 24, 2013
Past Presentation: Files added
->May 24, 2013
Publications: Updated
->May 17, 2013
Dear Healthcare Professional Letter of Rapid Safety Communication: Careram® Tablets 25mg; KOLBET® Tablets 25mg (Iguratimod) - Risk of severe haemorrhages by a suspected interaction with warfarin
->May 10, 2013
PMDA Risk Communication: Drug safety information which has come under review by the MHLW/PMDA (Interferon Beta (Products that have combination use of Ribavirin), Ribavirin, Tolvaptan, Levetiracetam, Paroxetine, Sugammadex, Loxoprofen, Nelarabine, Carboplatin, and Tegafur / Gimeracil / Oteracil Potassium) posted.
->May 8, 2013
PMDA Medical Safety Information

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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
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Past Presentations
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Frequently Asked Questions (FAQ)
About 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