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News & Press: Regulatory Updates

PHSS Oct 2017 Regulatory Update ; EMA relocation preparedness; Perils of antimicrobial resistance

08 November 2017   (0 Comments)
Posted by: Tamsin Marshall
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PHSS Regulatory Update October 2017


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 Australian, EU, USA and PIC/S regulatory authorities plus ICH.

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



  • Update on EMA relocation preparedness

  •  Strategic inquiry into pre-submission activities organised by the EMA (EU Ombudsman)

  •  Raising awareness of the perils of antimicrobial resistance

  • Updated guidelines on the quality and safety of tissues and cells for human application


  • Biosimilars - statistical approaches to evaluate analytical similarity
  • Advancement of emerging technology applications for pharmaceutical innovation and modernization
  • Strengthening FDA’s inspection and oversight of drug manufacturing
  • Indexing of legally marketed unapproved new animal drugs for minor species # 210.



  • Updated GMP Clearance application forms


  • ICHQ11 Q&As


  • Iran, Turkey and Mexico / accede to PIC/S


  • Factor VIII medicines


  • Points to Consider for Ageing Facilities

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