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News & Press: Regulatory Updates

PHSS Regulatory Update March 2015

13 March 2015  
Posted by: Tamsin Marshall
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PHSS Regulatory Monthly Update March 2015 

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, PIC/S and USA regulatory authorities.

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

Europe

  • Concept paper - revision of annex 1 EU GMP - manufacture of sterile medicinal products
  • Identification of medicines: EU task force to implement new international standards
  • New manufacturing and wholesale dealer licences

USA

  • New draft documents related to compounding of human drugs
  • Safety considerations to mitigate the risks of misconnections with small-bore connectors intended for enteral applications
  • USP Chapter <1790> Visual Inspection of Injections

Products

  • UK Regulator warns against GcMAF made in unlicensed facility in Cambridgeshire
  • USFDA requires label warnings to prohibit sharing of multi-dose diabetes pen devices among patients

 


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