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News & Press: Regulatory Updates

PHSS Regulatory Update January 2013

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

INTRODUCTION

During the last 4 weeks there have been a number of developments in the regulation of the pharmaceutical industry. This month all reported issues have come from the EU and USA regulatory authorities.

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

Europe

· Guideline - setting health based limits for risk identification in the manufacture of different medicinal products in shared facilities

· Revisions to EU GMP chapters 3,5,6 &8

· Variations guidelines - Outcome of the public consultation

· Variations guidelines - Outcome of the public consultation

· Framework for a close collaboration with Israel in place

· UK Govt. response to EU consultation on a common logo for legally operating online pharmacies

USA

· Draft guidance on abuse-deterrent opioids

· Proposed guidance documents for 2013

· cGMP Requirements for Combination Products – Final Rule


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