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News & Press: Regulatory Updates

PHSS Regulatory Update September 2013

29 November 2013  
Posted by: Tamsin Marshall
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PHSS Regulatory Update September 2013

INTRODUCTION

During the last 4 weeks there have been a number of developments in the regulation of the pharmaceutical industry. This month reported issues have come from the EU, USA and Australian regulatory authorities and also from ICH. It is disturbing to note yet another incident of bacterial contamination in sterile products manufactured in the USA by a compounding pharmacy.

The topics covered in this edition of the "Update” include:

Europe

· Concept paper on development of product-specific guidance on demonstration of bioequivalence

· First conclusions of parallel assessment of quality-by-design applications

· Reflection paper on general issues for consideration regarding coated nanomedicines

· Requirements for Change of Ownership submissions

USA

· Guidance for Industry: Safety Labeling Changes

· Safety Alert - Sterile Products from Specialty Compounding

· Withdrawal of draft Guidances Issued Before 2010

International

Australia

· TGA international engagement strategy 2013-2015 ICH

ICH

· Q3D Guideline for Elemental Impurities

Products

· Antibacterial fluoroquinolone drugs taken by mouth or by injection


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