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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

January 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
16 Dec 2011 Draft Guidance on "Process Validation : Terminal Sterilization Processes for Pharmaceutical Products"
16 Dec 2011 Health Canada Issues Consultation on "Cleaning Validation Guidance"
09 Dec 2011 European Medicines Agency and United States Food and Drug Administration to share manufacturing site inspections
08 Dec 2011 Health Canada Issues Consultation on "Draft Guidance on Classification of Observations for Inspection of Cells, Tissues and Organs Establishments"
08 Dec 2011 New Chairman Appointed to the Board of Singapore's Health Sciences Authority
08 Dec 2011 Australia's TGA to improve regulation of therapeutic goods
08 Dec 2011 Australian TGA reforms: a blueprint for TGA's future
06 Dec 2011 US FDA announces regulatory site visit training program


November 2011

30 Nov 2011 US GAO recommends better coordination to enhance efforts to address economic adulteration
28 Nov 2011 ICH S2(R1) Reaches Step 4 of the ICH Process
28 Nov 2011 Australian TGA seeking comments on proposed revisions to regulatory guidelines for over the counter medicines
24 Nov 2011 China's SFDA issues Guiding Opinions on Enhancing the Construction of Adverse Drug Reaction Monitoring System



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