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FY2011
November 30, 2011-
Report on the 4th China-Korea-Japan Director-General Meeting and Working Group on Pharmaceutical Affairs are posted
- November 29, 2011
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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
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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 (PDF)
- June 3 , 2011
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Executive Summary of Pharmaceuticals and Medical Devices Safety Information posted: No 279, 2011
- May 24 , 2011
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English translation of review report: Januvia/Glactiv
- May 24 , 2011
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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 (PDF)
- 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 (PDF)
- April 6 , 2011
- 2011 PMDA Updates (PDF)
FY2010
- March 31, 2011
- Executive Summary of MHLW Pharmaceuticals and Medical Devices Safety Information posted: No 278, 2011
- March 30, 2011
- MHLW Pharmaceuticals and Medical Devices Safety Information posted: No 277, 2011
- March 29, 2011
- English translations of Administrative Notices: "Format for Preparing the Common Technical Document for Submission of New Drug Applications to Reduce Total Review Time", "Points to Consider for Reducing Total Review Time for New Drug Applications"
- March 24, 2011
- English translations of Ministerial Ordinances on GCP for Drugs/Medical Devices posted
- March 16, 2011
- 2011 Tohoku - Pacific Ocean Earthquake - PMDA's Current Situation -
- March 14, 2011
- Tohoku district - off the Pacific Ocean Earthquake - PMDA's current situation and its response -
- March 8, 2011
- English Translation of PMDA Notification No.0206007, "Procedures for Public Release of Information on Review of Applications for New Medical Devices," posted.
- March 4, 2011
- Executive Summary of MHLW Pharmaceuticals and Medical Devices Safety Information posted: No 277, 2011
- February 25, 2011
- MHLW Pharmaceuticals and Medical Devices Safety Information posted: No 276, 2011
- February 23, 2011
- English translation of review report: Xolair for subcutaneous injection
- February 16, 2011
- New drug approvals: April - September 2010
New medical device approvals: April - September 2010
- February 9, 2011
- PMDA Medical Safety Information： No.19（September, 2010）
- February 8, 2011
- PMDA Updates (January, 2011) posted
- February 3, 2011
- Executive Summary of MHLW Pharmaceuticals and Medical Devices Safety Information posted: No 276, 2011
- February 2, 2011
- English translation of review report: Remitch
- January 31, 2011
- MHLW Pharmaceuticals and Medical Devices Safety Information posted: No 275, 2010
Record of Consultation on Pharmacogenomics/Biomarkers: Drug-induced kidney injury biomarkers
- January 26, 2011
- PMDA "MIHARI" project−Medical Information for Risk Assessment Initiative
- January 17, 2011
- PMDA Updates (December, 2010) posted
- December 28, 2010
- MHLW Pharmaceuticals and Medical Devices Safety Information posted: No 274, 2010
- December 15, 2010
- PMDA Updates (November, 2010) posted
- November 26, 2010
- Ministry of Health, Labour and Welfare (MHLW) and PMDA concluded Confidentiality Arrangement with the Swiss Agency for Therapeutic Products (Swissmedic).
- November 15, 2010
- PMDA Updates (October, 2010) posted
- October 29, 2010
- MHLW Pharmaceuticals and Medical Devices Safety Information posted: Issue of 272, 2010
- October 28, 2010
- Ministry of Health, Labour and Welfare (MHLW) and PMDA concluded Confidentiality Arrangement with the Medicines and Healthcare products Regulatory Agency (MHRA).
- October 21, 2010
- PMDA Medical Safety Information
- October 20, 2010
- PMDA Request for Proper Use of Drugs No. 1, 2010 (PDF)
- October 19, 2010
- Annual Report FY 2009 posted
- October 6, 2010
- PMDA Updates (September, 2010) posted
- September 30, 2010
- New drug approvals: April-May 2010.
- September 30, 2010
- Lists of Products approved in FY 2009 are posted.
- September 27, 2010
- News Release: PMDA participated in China-Korea-Japan Director-General meeting and APEC Multi-Regional Clinical Trials Seoul Workshop Highlighting Korea, China and Japan Tripartite Symposium (PDF)
- September 8, 2010
- PMDA Updates (August, 2010) posted
- September 6, 2010
- "PMDA 5th International Symposium on Biologics (Presentation files are posted)"
- August 31, 2010
- MHLW Pharmaceuticals and Medical Devices Safety Information posted: Issue of 271, 2010
- August 20, 2010
- "PMDA 5th International Symposium on Biologics (AGENDA update)"
- August 6, 2010
- English translation of review report: Isentress
- August 5, 2010
- PMDA Updates (July, 2010) posted
- August 2, 2010
- "PMDA Training Seminar"
- July 30, 2010
- MHLW Pharmaceuticals and Medical Devices Safety Information posted: Issue of 270, 2010
- July 23, 2010
- "PMDA 5th International Symposium on Biologics (Speaker information update)"
- July 1, 2010
- PMDA Updates (June, 2010) posted
- June 30, 2010
- MHLW Pharmaceuticals and Medical Devices Safety Information posted: Issue of 269, 2010
- June 25, 2010
- 2010 China-Japan Symposium on Global Clinical Trials and Ethnic Factors(Presentation files are posted)
- June 24, 2010
- "PMDA 5th International Symposium on Biologics".
- June 23, 2010
- PMDA Medical Safety Information
- June 8, 2010
- PMDA Updates (May, 2010) posted
- June 7, 2010
- May 28, 2010 News Release: PMDA co-hosted "Symposium on global clinical trials and ethnic factors was held in Beijing" (PDF)
- May 28, 2010
- MHLW Pharmaceuticals and Medical Devices Safety Information posted: Issue of 268, 2010
- May 20, 2010
- Ministry of Health, Labour and Welfare (MHLW) and PMDA concluded Confidentiality Arrangement with the Health Sciences Authority of Republic of Singapore (HSA).
- May 10, 2010
- PMDA Updates (April, 2010) posted
- April 27, 2010
- MHLW Pharmaceuticals and Medical Devices Safety Information posted: Issue of 267, 2010
- April 13, 2010
- PMDA Medical Safety Information
- April 5, 2010
- Past Presentation (DIA 22nd Annual EuroMeeting) posted
FY2009
- March 31, 2010
- PMDA Updates (March, 2010) posted
- March 29, 2010
- MHLW Pharmaceuticals and Medical Devices Safety Information posted: Issue of 266, 2010
- March 25, 2010
- "Points to Consider When Applying for Marketing Approval for Medical Devices: PFSB/ELD/OMDE Notification No.0216001" posted.
- March 12, 2010
- English translation of review report: Macugen
- March 9, 2010
- PMDA Updates (January/February, 2010) posted
- March 8, 2010
- English translation of review report: GORE TAG Thoracic Aortic Stent Graft System
- March 3, 2010
- MHLW Pharmaceuticals and Medical Devices Safety Information posted: Issue of 265, 2009
- March 1, 2010
- PMDA dispatched its liaison to Washington D.C.
- February 23, 2010
- Past Presentations posted
- February 15, 2010
- PMDA Medical Safety Information
- January 29, 2010
- MHLW Pharmaceuticals and Medical Devices Safety Information posted: Issue of 264, 2009
- January 27, 2010
- Summary of New Regulations of Non-Corrective Colored Contact Lenses under PAL is posted.
- January 18, 2010
- PMDA Medical Safety Information
- December 25, 2009
- "Cancellation of items registered in Drug Master Files: PFSB/ELD Notification No.0208001" is posted.
- December 25, 2009
- MHLW Pharmaceuticals and Medical Devices Safety Information posted: Issue of 263, 2009
- December 25, 2009
- News Release: The 2nd China-Japan-Korea Director-General Meeting was held in Beijing
- December 18, 2009
- English translation of review report: Endeavor Coronary Stent System
- December 17, 2009
- English translation of review report: JACE
- December 17, 2009
- International Programs section opens on PMDA website.
- November 30, 2009
- MHLW Pharmaceuticals and Medical Devices Safety Information posted: Issue of 262, 2009
- November 5, 2009
- Ministry of Health, Labour and Welfare (MHLW) and PMDA concluded Confidentiality Arrangement with Health Canada and European Commission (EC).
- November 2, 2009
- English translation of review report: Actemra
- October 30, 2009
- MHLW Pharmaceuticals and Medical Devices Safety Information posted: Issue of 261, 2009
- October 28, 2009
- PMDA has held the “PMDA 4th International Symposium on Biologics”. (Presentation files are posted)
- October 26, 2009
- "Re: Q & A on use-results surveys conducted as All-Case Surveillance and Early Post-Marketing Phase Vigilance (EPPV) for Prescription Drugs： PFSB/ELD・SD Notice, dated September 7, 2009" is posted. (PDF)
- October 8, 2009
- Annual Report FY2008 is posted.
- September 11, 2009
- MHLW Pharmaceuticals and Medical Devices Safety Information posted: Issue of 260, 2009
- September 8, 2009
- PMDA 4th International Symposium on Biologics (Registration open)
- September 8, 2009
- MHLW Pharmaceuticals and Medical Devices Safety Information posted: Issue of 259, 2009
- September 3, 2009
- PMDA Medical Safety Information
- July 14, 2009
- PMDA Medical Safety Information
- July 9, 2009
- Second Mid-term Targets/Plan (FY2009 to 2013) are posted.
- July 8, 2009
- English translation of review report: Thaled Capsule 100
- July 7, 2009
- English translation of review report: Pirespa
- May 15, 2009
- "PMDA International Strategic Plan" is posted.
- April 20, 2009
- MHLW Pharmaceuticals and Medical Devices Safety Information posted: Issue of 256, 2009
FY2008
- March 19, 2009
- Notifications on Medical Devices are posted.
- March 17, 2009
- PMDA opened Japanese Pharmacopoeia English website.
- March 16, 2009
- English translation of review reports: Adsorbed Influenza Vaccine (H5N1) "HOKKEN" and Adsorbed Influenza Vaccine (H5N1) "BIKEN"
- March 13, 2009
- MHLW Pharmaceuticals and Medical Devices Safety Information posted: Issue of 255, 2009
- March 6, 2009
- PMDA English website relaunched.
- March 5, 2009
- PMDA has held the "PMDA 3rd International Symposium on Biologics". (Presentation files are posted)
- February 18, 2009
- MHLW Pharmaceuticals and Medical Devices Safety Information posted: Issue of 254, 2009
- February 10, 2009
- PMDA Medical Safety Information : Issue of June, 2008 [No.5]
- February 9, 2009
- English translation of review report: Avastin
- February 5, 2009
- PMDA will hold the "PMDA 3rd International Symposium on Biologics". (Registration closed)
- January 14, 2009
- ”Master File System for Drug Substances, etc.” is posted.
- January 9, 2009
- MHLW Pharmaceuticals and Medical Devices Safety Information posted: Issues of 252 -253, 2008
- December 26, 2008
- PMDA Medical Safety Information: Issue of October, 2008 [No.6]
- November 28, 2008
- Set up of the Office of International Programs (PDF)
- November 18, 2008
- Annual Report FY2007 is posted.
- November 17, 2008
- "Q&A on the Master File (MF) System" is posted.
- October 3, 2008
- PMDA Medical Safety Information : Issue of June, 2008 [No.4]
- October 29, 2008
- MHLW Pharmaceuticals and Medical Devices Safety Information posted: Issue of 240, 2007
- October 24, 2008
- English translation of review report: Myozyme
- October 23, 2008
- PMDA Profile of Services 2008 revised to add our Philosophy. (PDF)
- October 17, 2008
- GMP Information is posted.
- August 29, 2008
- English translation of review report: Topina
- June 20, 2008
- "Points to Be Considered by the Review Staff Involved in the
Evaluation Process of New Drug" is posted. (PDF)
- May 9, 2008
- PMDA English website relaunched.
- April 24, 2008
- Presentation files (PDF) are updated in the Website of "East Asian Pharmaceutical Regulatory Symposium 2008".
FY2007
FY2006
