Post-marketing Safety Relief Services for Adverse Health Effects Drug and Medical Device Reviews
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What's NewBack number
IconFebruary 21, 2012New
MHLW Pharmaceuticals and Medical Devices Safety Information posted: No 287, 2012
IconFebruary 20, 2012New
3rd China - Japan Symposium on Drug Development- focusing on Current Status of
Global Clinical, Trials Utilization of Clinical Data and Clinical Trial Consultation System -
IconFebruary 17, 2012New
PMDA Risk Communications updated
IconFebruary 17, 2012New
English translation of review report: Rasilez
IconFebruary 16, 2012
Extension of Confidentiality Arrangement between EC/EMA and
MHLW/PMDA (PDF)
IconFebruary 14, 2012
New drug approvals: April - December 2011
New medical device approvals: April - September 2011
IconFebruary 13, 2012
PMDA request for proper use of drugs: Compliance with Dosage and Administration and Ensuring Early Detection for Lamictal Tablets (lamotorigine)-induced Serious Skin Disorders posted
IconFebruary 2, 2012
PMDA International Vision - PMDA EPOCH Toward 2020
IconJanuary 31, 2012
PMDA Updates (January, 2012) posted
IconJanuary 30, 2012
PMDA request for proper use of drugs: Periodic blood tests and symptom checks should be performed for prevention and early detection of agranulocytosis associated with the antithyroid drug thiamazole posted
IconJanuary 25, 2012
Executive Summary of Pharmaceuticals and Medical Devices Safety Information posted: No 287, 2012
IconJanuary 25, 2012
MHLW Pharmaceuticals and Medical Devices Safety Information posted: No 286, 2011
IconJanuary 24, 2012Update
PMDA Risk Communications　(Drug Risk Information of ongoing evaluation, dated January 20, 2012)　posted
IconJanuary 24, 2012
PMDA participates in the EMA-FDA pilot program for Quality by Design as an observer.
IconJanuary 18, 2012Update
PMDA Risk Communication“Update on Ongoing PMDA/MHLW Review of the Safety of Somatoropin-containing Medicines”posted
IconJanuary 16, 2012
The Basic Concept on Regulatory Science in PMDA posted
IconJanuary 12, 2012
PMDA Risk Communication: MHLW/PMDA starts review of Rasilez (Aliskiren Fumarate) : Communication on combination therapy of Rasilez with an ACE inhibitor or ARB to hypertension patients with complication of diabetes posted
IconJanuary 12, 2012Update
PMDA Risk Communications (Drug Risk Information of ongoing evaluation) posted
IconJanuary 6, 2012
Executive Summary of Pharmaceuticals and Medical Devices Safety Information posted: No 286, 2011
IconDecember 28, 2011
PMDA Medical Safety Information
IconDecember 28, 2011
PMDA Updates (December, 2011) posted
IconDecember 27, 2011
MHLW Pharmaceuticals and Medical Devices Safety Information posted: No 285, 2011
IconDecember 14, 2011
New drug approvals: April – September 2011
IconDecember 14, 2011
New medical device approvals: April – June 2011
IconDecember 13, 2011
PMDA Risk Communication: Japan’s view on Avastin (bevacizumab) approval for the breast cancer indication posted
IconDecember 13, 2011Update
PMDA Risk Communications (Drug Risk Information of ongoing evaluation) posted
IconDecember 2, 2011
Executive Summary of Pharmaceuticals and Medical Devices Safety Information posted: No 285, 2011
IconDecember 1, 2011
PMDA Updates (November, 2011) posted
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
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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