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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 2011

26 Jan 2011 EDQM begins development of a demonstrator of its' future ‘TRACK AND TRACE' system
26 Jan 2011 European Medicines Agency publishes final ‘Road map to 2015’
24 Jan 2011 US FDA Updates Process Validation Guideline
21 Jan 2011 Guideline of the National Institute of Pharmacy on the right choice of names for medicinal products for human use
14 Jan 2011 Analysis: Revision of EU Annex 11 and Chapter 4
13 Jan 2011 EU releases revised Annex 11 on Computerized Systems
12 Jan 2011 Global Regulatory News   245 KB  Members only
11 Jan 2011 The Maltese Medicines Authority launches an information campaign on medicines.
10 Jan 2011 Germany Publishes Advice on Harmonisation of Product Information Texts for Medicinal Products with Identical Active Substances
10 Jan 2011 EU Committee for Medicinal Products for Veterinary Use (CVMP) publishes new draft strategy on combating antimicrobial resistance
10 Jan 2011 Malaysia Publishes Guidelines on Good Distribution Practices
07 Jan 2011 US FDA Warns Public of Continued Extortion Scam by FDA Impersonators
06 Jan 2011 US FDA launches website to help regulated industries save time, resources
04 Jan 2011 Sharfstein leaving FDA
03 Jan 2011 Universal Standards Proposed for Prescription Container Labels to Help Reduce Medication Misuse, Promote Patient Understanding
01 Jan 2011 PIC/S Adopts Revision of the Explanatory Notes for Industry on the Preparation of a Site Master File (PE 008-4).


December 2010

30 Dec 2010 The Inaugural Conference of the tenth Chinese Pharmacopoeia Commission and the 60th Anniversary Ceremony of Chinese Pharmacopoeia held in Beijing
22 Dec 2010 Updated Danish Drug Standards
22 Dec 2010 European Medicines Agency and European Centre for Disease Prevention and Control agree to enhance co-operation
21 Dec 2010 US Good Laboratory Practice for Nonclinical Laboratory Studies - Advance notice of proposed rulemaking



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