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February 2011

01 Feb 2011 Dutch Medicines Evaluations Board Releases Statistics About Its Performance

 

January 2011

27 Jan 2011 Three government agencies jointly issue notice on strengthening the supervision of prepared slices of Chinese crude drugs
26 Jan 2011 Health Canada Publishes Summary Report: Stakeholder Consultations on the Good Manufacturing Practices (GMP) Inspection Program Review
26 Jan 2011 Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 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).

 

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