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FY2009
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 ¡ÈPMDA 4th International Symposium on Biologics¡É. (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
