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What's New at EMA Members only

What’s New at MHLW Members only

April 2012

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 Health Canada Publishes "Guidance on Classification of Observations for Inspection of Cells, Tissues and Organs Establishments (GUI-0101)"
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
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 US FDA Issues DTC Television Ad Guidance
12 Mar 2012 EudraLex - Volume 2 - Pharmaceutical Legislation Notice to applicants and regulatory guidelines medicinal products for human use.
09 Mar 2012 British MHRA's Red Tape Challenge – medicines regulations in the spotlight
08 Mar 2012 US could bring more common drugs over the counter
07 Mar 2012 US FDA: Keeping The Focus on Scientific Integrity
07 Mar 2012 Taiwanese FDA Explains the Rules on Processing Marketed Products that Fail the Random Inspection

 

Last Update: 18 May 2012

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