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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

April 2012

21 Apr 2012 US FDA says focused on tracking drugs after approval
19 Apr 2012 Slovakia Issues Annual Report of the State Institute for Drug Control 2011 (in Slovak)
17 Apr 2012 U.S. top court rules for generic drugmaker on patent
17 Apr 2012 Korea applies for PIC/S membership
11 Apr 2012 European Medicines Agency publishes new document on regulatory procedural advice on similar biological medicines
10 Apr 2012 US FDA Creates New Standard For Cargo Theft
09 Apr 2012 Japanese PMDA Presentation: PMDA-Vision: It's Current Situation and Aim for the Future
04 Apr 2012 Health Canada Issues "Quality System Framework for the Inspectorate Quality Management System (QM-0001) - 2012"
04 Apr 2012 Dr. Zuzanu Zvolen Appointed Slovak Minister of Health
04 Apr 2012 Chairman of top EU drugs committee quits suddenly
04 Apr 2012 US Institute of Medicine Issues Report: Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad
04 Apr 2012 Health Canada Publishes "Guidance on Classification of Observations for Inspection of Cells, Tissues and Organs Establishments (GUI-0101)"
02 Apr 2012 Estonian State Agency of Medicine Launches New Website
02 Apr 2012 Japan applies for PIC/S membership
02 Apr 2012 New PIC/S Aide-Memoire: Aide-Memoire on Assessment of Quality Risk Management Implementation


March 2012

26 Mar 2012 European Medicines Agency Management Board strengthens conflicts of interest policies and transparency
23 Mar 2012 US FDA Considers Expanding Definition of Nonprescription Drugs
20 Mar 2012 US FDA Amends Labeling Requirements in 21 CFR Part 211
12 Mar 2012 EudraLex - Volume 2 - Pharmaceutical Legislation Notice to applicants and regulatory guidelines medicinal products for human use.
12 Mar 2012 US FDA Issues DTC Television Ad Guidance



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