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News & Press: Regulatory Updates

PHSS Regulatory Update November 2012

29 November 2013  
Posted by: Tamsin Marshall
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PHSS Regulatory Update November 2012

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, Canadian and WHO regulatory authorities plus ICH

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

Europe

· Changes to variation rules start to apply from 2 November 2012

· Public consultation on the revision of European legislation on medical devices

· Reflection paper on medicinal product supply shortages caused by manufacturing / GMP Compliance problems

· Draft Concept paper on revision of Annex 15 of the GMP guide

· Draft Concept paper on revision of Annex 17 of the GMP guide

· 144th Session of the European Pharmacopoeia Commission

· eTACT

International

Canada

· Risk Classification of Good Manufacturing Practices (GMP) Observations GUI-0023

ICH

· ICH Q7 Q&As Final Concept Paper

WHO

· Annex 2 WHO GMP: water for pharmaceutical use

· Annex 5 Development of paediatric medicines: points to consider in formulation


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