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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

February 2012

14 Feb 2012 European Medicines Agency and European Commission extend confidentiality arrangement with Japan
10 Feb 2012 FDA sets draft rules for biotech drug copies
09 Feb 2012 FDA Office of Generic Drugs Releases Example of QbD for ANDAs
08 Feb 2012 Dutch Medicines Evaluation Board is moving to Utrecht
08 Feb 2012 New national Medicines Information Strategy for Finland
07 Feb 2012 Commissioner of US Food and Drug Administration reflects on the history and importance of regulation in blog post
01 Feb 2012 SFDA Launches Saudi Code of Ethics for Marketing of Pharmaceutical Products


January 2012

31 Jan 2012 US GAO concludes that FDA needs to do more to ensure that drug labels contain up-to-date information
23 Jan 2012 Danish Medicines Agency Creates Smart Phone App Allowing Consumers To Look Up Medicines
20 Jan 2012 European Medicinces Agency submits concept paper for public consultation: Delegated act on the principles and guidelines of good manufacturing ...
16 Jan 2012 Japanese PMDA publishes "The Basic Concept on Regulatory Science in PMDA"
16 Jan 2012 Korean FDA publishes main tasks of year 2012
16 Jan 2012 Global Regulatory News   200 KB  Members only
11 Jan 2012 M3(R2) Q&As on Combination Drug Toxicity Testing available on the ICH website
09 Jan 2012 Britain launches new MHRA website home page
05 Jan 2012 Danish Medicines Agency creates new medical devices website
04 Jan 2012 USP Proposes Standard to Offer Best Practices to Help Ensure Supply Chain Integrity, Reduce Risks of Counterfeit or Mishandled Medicine


December 2011

28 Dec 2011 Chinese SFDA Commissioner Shao Mingli meets Vice President of the Council of Ministers of Cuba
27 Dec 2011 SFDA issues Document Standard for Administrative Law Enforcement on Health Food and Cosmetics Supervision (interim)
19 Dec 2011 Australian TGA publishes presentations on manufacturing thereapeutic goods



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