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What's New at FDA  Members only

What's New at EMA Members only

What’s New at MHLW Members only

June 2009

03 Jun 2009 US FDA Establishes Transparency Task Force
02 Jun 2009 ICH Topic Q8, Q9 and Q10 Note for guidance on Pharmaceutical Development Quality Risk Management Pharmaceutical Quality System Questions and Answers


May 2009

27 May 2009 Australia Publishes Office of Manufacturing Quality presentation: The TGA and Process Analytical Technology
27 May 2009 US HHS Secretary Kathleen Sebelius swears in Dr. Margaret Hamburg as the Commissioner of Food and Drugs, May 22, 2009
22 May 2009 Hamburg Sworn In as New Commissioner of Food and Drugs
19 May 2009 Finland's government proposes establishing new national Medicines Agency
19 May 2009 Finland's government proposes establishing a new national Medicines Agency
18 May 2009 PIC/S Publishes 2008 Annual Report
18 May 2009 The 28th PIC/S Committee meeting took place in Geneva on 5-6 May 2009.
15 May 2009 Australia's TGA Publishes Prescription Medicines Business Process Improvement Project
15 May 2009 Japan's PMDA Releases International Strategic Plan
15 May 2009 India's Central Drugs Standard Control Organization Proposes Pharma Zone for Airports and Seaports
15 May 2009 Free PharmAsia News Article - China Issues Healthcare Reform Plan
08 May 2009 Health Canada Publishes Good Manufacturing Practices (GMP) Guidelines - 2009 Edition (GUI-0001)
08 May 2009 Statement of Senator Edward M Kennedy on the Nomination Of Dr. Margaret Hamburg to Be FDA Commissioner
07 May 2009 Press release: MHRA data to be available to medicines regulators across EU
07 May 2009 US President's FY 2010 Budget for FDA Invests Substantially in Food and Medical Product Safety
06 May 2009 European Court of Justice judgment on the definition of advertising in Directive 2001/83/EC
06 May 2009 MHRA Data to be Available to Medicines Regulators Across EU
05 May 2009 Australia's TGA Publishes their Approach to Regulating PAT



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