February 6, 2012
- Scheduled Server Maintenance : Feb 7, 2012
- February 2, 2012
- PMDA International Vision - PMDA EPOCH Toward 2020
- January 31, 2012
- PMDA Updates (January, 2012) posted
- January 25, 2012
- Executive Summary of Pharmaceuticals and Medical Devices Safety Information posted: No 287, 2012
- 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 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 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 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
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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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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 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 :Update on Ongoing PMDA/MHLW Review the Safety of Somatoropin-containing Medicines (Japanese version posted date 29 July 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 9, 2011
- News Release - MHLW/PMDA delegation visited China SFDA - posted
- September 9, 2011
- New drug approvals: April - June 2011
- Scientific reviews and conformity audits of marketing authorization applications of drugs and medical devices, clinical trial consultations
- Collection, analysis and dissemination of information related to the quality, efficacy and safety of pharmaceuticals and medical devices
- Providing financial assistance for individuals affected by adverse drug reactions or infections from biological products
- Implementation of PMDA International Strategic Plan through international regulatory harmonization, bilateral relationship, effective communication with relevant external parties, etc.
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