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News & Press: Regulatory Updates

PHSS Regulatory Update August 2014

06 August 2014  
Posted by: Tamsin Marshall
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PHSS Regulatory Update August 2014


During the last 4 weeks there have been a number of developments in the regulation of the pharmaceutical industry. This month most reported issues have come from the EU and USA regulatory authorities. Once again there is note of lack of sterility assurance on products from two different  compounding pharmacies in the USA. In one of these incidents the FDA formally requested a recall. There is also note of a multi batch product  recall in the UK following the potential for chemical contamination of product which was discovered during an MHRA inspection.

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

  • EP Commission validates strategy for elemental impurities and upcoming ICH Q3D guideline
  • Australian TGA joins EDQM’s CEP assessment process
  • Focus on enforcement review of pharmaceutical manufacturing and production sector
  • MHRA guidance notes 5 and 6 have been updated


  • Guidance for Industry Neglected Tropical Diseases(NTD) of the Developing World: Developing Drugs for Treatment or Prevention
  • Fostering Cooperation and Strengthening Medical Product Regulatory Systems in the Americas
  • Guidance for Industry CGMP — Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act
  • Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act



  • Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk  (M7)
  • Heath Canada (HC) and Swissmedic are now Steering Committee members.


  • Class 2 medicines recall Buccolam Oromucosal Solution manufactured by ViroPharma
  • Sterile drugs from Downing Labs (aka NuVision Pharmacy)

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