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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

March 2011

09 Mar 2011 Regulatory Affairs Forum, Wednesday 13th April 2011
07 Mar 2011 US Supreme Court won't review drug patent deal
04 Mar 2011 Health Canada Finalizes Good Manufacturing Practices (GMP) Guidelines 2009 Edition, Version 2 (GUI-0001)
01 Mar 2011 WHO: Chinese national regulatory authority meets international standards


February 2011

28 Feb 2011 US FDA and Georgetown University Medical Center announce partnership
28 Feb 2011 Britain's MHRA Publishes Annual report on the regulation of medicines advertising
28 Feb 2011 FDA on Final Process Validation Guidance: Focus on Concepts, Not Terminology
22 Feb 2011 Hungarian National Insitute of Pharmacy Publishes Validation Criteria For New Applications
21 Feb 2011 Health Canada Publishes Quality System Framework 2011
18 Feb 2011 New Cooperation Agreement between PIC/S and EMA
18 Feb 2011 Who Addresses Improving Acess to Generic Medicines
15 Feb 2011 FDA Publishes MAPP on Applying ICH Q8, Q9, and Q10 Principles to CMC Review
15 Feb 2011 Irish Medicines Board Publishes Strategic Plan 2011 – 2015
15 Feb 2011 Irish Medicines Board Publishes 2009 Annual Report
15 Feb 2011 China's SFDA Publishes Good Manufacturing Practice for Pharmaceutical Products (2010 revised edition)
14 Feb 2011 European Medicines Agency and Swissmedic extend confidentiality arrangement
14 Feb 2011 European Medicines Agency launches web survey to gather feedback on online user experience
14 Feb 2011 Submissions to Australia's Call for input: Review to improve transparency of the Therapeutic Goods Administration (TGA)
11 Feb 2011 European Medicines Agency sets out work priorities for 2011
08 Feb 2011 US FDA Announces Medical Device Innovation Initiative



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