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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

May 2013

03 May 2013 Details on European Medicines Agency reorganisation
01 May 2013 US FDA Commissioner addresses using a public health approach to regulatory processes


April 2013

26 Apr 2013 US Senate Committee releases Draft Proposal on Pharmaceutical Compounding
26 Apr 2013 EMA releases Guideline on Similar Biological Medicinal Products
24 Apr 2013 Australia has been added to the "list of third countries" in the EU regarding standards of manufacturing
23 Apr 2013 Dutch Medicines Evaluation Board Gets New Deputy Director
16 Apr 2013 European Medicines Agency publishes 2012 annual report
16 Apr 2013 CFDA Commissioner Zhang Yong meets the delegation of Swedish Ministry of Health and Social Affairs
15 Apr 2013 EC introduces Quality Risk Management into revised Guideline on Good Distribution; ISPE helps Members prepare
11 Apr 2013 Medicines and Healthcare Products Regulatory Agency launches its 2013-2018 corporate plan
10 Apr 2013 US FDA publishes budget request for fiscal year 2014
08 Apr 2013 Japanese MHLW joins Japan’s first Public-Private Partnership to facilitate the R&D of new health technologies for the developing world
08 Apr 2013 China obtains ISO/TC150/SC7 voting rights


March 2013

21 Mar 2013 Chinese SFDA adopts newly revised Good Supply Practice for Pharmaceutical Products
19 Mar 2013 Dutch Medicines Evaluation Board releases public consultation on its Strategic Business Plan for 2014-2018
19 Mar 2013 US FDA names Kathleen Uhl acting director, office of generic drugs
15 Mar 2013 European Medicines Agency and European Commission renew confidentiality arrangement with Canada
15 Mar 2013 European Medicines Agency updates product information template to label medicines subject to additional monitoring and encourage adverse ...
14 Mar 2013 European Union Adopts Good Distribution Practice Guidelines
13 Mar 2013 Working with the US FDA Office of the Ombudsman



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