FY2011
- March 30, 2012
3rd China - Japan Symposium on Drug Development- focusing on Current Status of Global Clinical Trials, Utilization of Clinical Data and Clinical Trial Consultation System - (Presentation files are posted) - March 27, 2012
MHLW Pharmaceuticals and Medical Devices Safety Information posted: No 288, 2012 - March 19, 2012
PMDA Risk Communications: Drug Risk Information of Ongoing Evaluation dated March 19, 2012 updated - March 19, 2012
PMDA Updates (March, 2012) posted - March 16, 2012
English translation of review report: Rasuritek - March 1, 2012
Executive Summary of Pharmaceuticals and Medical Devices Safety Information posted: No 288, 2012 - February 29, 2012
PMDA Medical Safety Information - February 29, 2012
PMDA Risk Communications: Drug Risk Information of Ongoing Evaluation dated February 24, 2012 updated - February 28, 2012
PMDA Updates (February, 2012) posted - February 27, 2012
Safety Information announced by MHLW: PFSB/SD Notification 0214-9 "Call attention to the Precautions of anti-influenza virus drugs" posted - February 21, 2012
MHLW Pharmaceuticals and Medical Devices Safety Information posted: No 287, 2012 - February 20, 2012
3rd China - Japan Symposium on Drug Development- focusing on Current Status of
Global Clinical, Trials Utilization of Clinical Data and Clinical Trial Consultation System - - February 17, 2012
PMDA Risk Communications updated - February 17, 2012
English translation of review report: Rasilez - February 16, 2012
Extension of Confidentiality Arrangement between EC/EMA and
MHLW/PMDA - February 14, 2012
New drug approvals: April - December 2011
New medical device approvals: April - September 2011 - February 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 - February 2, 2012
PMDA International Vision - PMDA EPOCH Toward 2020 - January 31, 2012
PMDA Updates (January, 2012) posted - January 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 - January 25, 2012
Executive Summary of Pharmaceuticals and Medical Devices Safety Information posted: No 287, 2012 - January 25, 2012
MHLW Pharmaceuticals and Medical Devices Safety Information posted: No 286, 2011 - January 24, 2012
PMDA Risk Communications (Drug Risk Information of ongoing evaluation, dated January 20, 2012) posted - January 24, 2012
PMDA participates in the EMA-FDA pilot program for Quality by Design as an observer. - January 18, 2012
PMDA Risk Communication??Update on Ongoing PMDA/MHLW Review of the Safety of Somatoropin-containing Medicines"posted - January 16, 2012
The Basic Concept on Regulatory Science in PMDA posted - January 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 - January 12, 2012
PMDA Risk Communications (Drug Risk Information of ongoing evaluation) posted - January 6, 2012
Executive Summary of Pharmaceuticals and Medical Devices Safety Information posted: No 286, 2011 - December 28, 2011
PMDA Medical Safety Information - December 28, 2011
PMDA Updates (December, 2011) posted - December 27, 2011
MHLW Pharmaceuticals and Medical Devices Safety Information posted: No 285, 2011 - December 14, 2011
New drug approvals: April – September 2011 - December 14, 2011
New medical device approvals: April – June 2011 - December 13, 2011
PMDA Risk Communication: Japan's view on Avastin (bevacizumab) approval for the breast cancer indication posted - December 13, 2011
PMDA Risk Communications (Drug Risk Information of ongoing evaluation) posted - December 2, 2011
Executive Summary of Pharmaceuticals and Medical Devices Safety Information posted: No 285, 2011 - December 1, 2011
PMDA Updates (November, 2011) posted - November 30, 2011
Report on the 4th China-Korea-Japan Director-General Meeting and Working Group on Pharmaceutical Affairs are posted - November 29, 2011
Recommendation of periodic liver function tests and monitoring of signs/symptoms for patients treated with the gout/hyperuricaemia treatment benzbromarone posted: No 4, 2011 - November 29, 2011
Hepatitis B viral growth associated with the use of drugs with immunosuppressive effects posted: No 3, 2011 - November 29, 2011
Automobile accidents associated with the use of smoking cessation aid CHAMPIX (varenicline tartrate) posted: No 2, 2011 - November 29, 2011
MHLW Pharmaceuticals and Medical Devices Safety Information posted: No 284, 2011 - November 10 , 2011
PMDA Risk Communications (Drug Risk Information of ongoing evaluation) posted - November 9, 2011
2011 APEC Multi-Regional Clinical Trials TOKYO Workshop Highlighting Korea, China and Japan Tripartite Symposium (Presentation files are posted) - November 1, 2011
Executive Summary of Pharmaceuticals and Medical Devices Safety Information posted: No 284, 2011 - November 1, 2011
PMDA Profile of Services 2011-2012 - October 27, 2011
PMDA Risk Communications (Drug Risk Information of ongoing evaluation) posted - October 27, 2011
PMDA Risk Communications Update on Ongoing PMDA/MHLW Review the Safety of Somatoropin-containing Medicines (Japanese version posted date 29 July 2011) - October 27, 2011
MHLW Pharmaceuticals and Medical Devices Safety Information posted: No 283, 2011 - October 21, 2011
PMDA Annual Report FY 2010 - October 20, 2011
PMDA Updates (September & October, 2011) posted - October 18, 2011
English translation of review report: Cervarix - October 12, 2011
2011 APEC MRCT TOKYO Workshop Program (finalized version) posted. - October 3, 2011
Executive Summary of Pharmaceuticals and Medical Devices Safety Information posted: No 283, 2011 - September 29, 2011
MHLW Pharmaceuticals and Medical Devices Safety Information posted: No 282, 2011 - September 9, 2011
News Release - MHLW/PMDA delegation visited China SFDA - posted - September 9, 2011
New drug approvals: April - June 2011 - September 9, 2011
New drug approvals: Fiscal year 2010
Medical device approvals: Fiscal year 2010 - September 1, 2011
Executive Summary of Pharmaceuticals and Medical Devices Safety Information posted: No 282, 2011 - August 30 , 2011
MHLW Pharmaceuticals and Medical Devices Safety Information posted: No 281, 2011 - August 29 , 2011
English translation of Memorandum of Understanding between the Ministry of Health, Labour and Welfare of Japan and the State Food and Drug Administration of the People's Republic of China regarding Framework for Dialogue and Cooperation - August 24 , 2011
PMDA Updates (August, 2011) posted - August 19, 2011
Press Release:Warnings and Alerting: Severe haemorrhages in patients treated with an anticoagulant "Prazaxa capsules" - August 17, 2011
2nd PMDA Training Seminar - August 4, 2011
Executive Summary of Pharmaceuticals and Medical Devices Safety Information posted: No 281, 2011 - August 2, 2011
Risk Management Plan Guidance (Draft) posted - August 1, 2011
PMDA Medical Safety Information - July 28, 2011
PMDA ??MIHARI" project-Medical Information for Risk Assessment Initiative - July 20 , 2011
2011 APEC MRCT TOKYO Workshop Program (revised draft) posted. - July 13 , 2011
PMDA Updates (July, 2011) posted - July 8 , 2011
Report from Washington DC Area No.8(June, 2011) posted - July 4 , 2011
Japanese Pharmacopoeia page is updated. - July 1, 2011
APEC Multi-Regional Clinical Trials TOKYO Workshop Highlighting Korea, China and Japan Tripartite Symposium - July 1, 2011
Executive Summary of Pharmaceuticals and Medical Devices Safety Information posted: No 280, 2011 - June 29 , 2011
MHLW Pharmaceuticals and Medical Devices Safety Information posted: No 279, 2011 - June 23 , 2011
Safety Measures for diabetes medication ??pioglitazone-containing products" - June 22 , 2011
PMDA Risk Communication:Updated information about pioglitazone and increased risk of bladder cancer (dated 16 June 2011) posted - June 20 , 2011
English translation of review report: Clozaril - June 17 , 2011
PMDA Updates (June, 2011) posted - June 3 , 2011
Executive Summary of Pharmaceuticals and Medical Devices Safety Information posted: No 279, 2011 - May 24 , 2011
English translation of review report: Januvia/Glactiv - May 24 , 2011
English translations of Notification/Administrative Notice: the Guideline for Clinical Evaluation of Oral Hypoglycemic Agents and the Q&As regarding the Guideline - May 17 , 2011
Report from Washington DC Area No.7(April, 2011) posted - May 16 , 2011
PMDA Updates (May, 2011) posted - May 13 , 2011
New drug approvals: April - December 2010
New medical device approvals: April - December 2010 - May 2 , 2011
Safety Information announced by MHLW is posted. :
e.g <Q and A> Resuming vaccination with the pediatric pneumococcal conjugate vaccine and the Hib vaccine (dated March 29 2011) - April 27 , 2011
MHLW Pharmaceuticals and Medical Devices Safety Information posted: No 278, 2011 - April 12 , 2011
The Second China-Japan Symposium on Drug Development March 29th 2011 in Beijing(Presentation flies are posted) - April 11 , 2011
PMDA News Release:The Second China - Japan Symposium on Drug Development focusing on IND, Pre-Consultation, GMP and DMF system - April 6 , 2011
2011 PMDA Updates