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News & Press: Regulatory Updates

PHSS Dec 2016 Regulatory Update ; EDQM share info w Japan reg; Safety Testing of drug metabolites

04 January 2017  
Posted by: Tamsin Marshall
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PHSS December Regulatory Update 2016


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 USA and EU regulatory authorities plus a guidance document from APIC.

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



  • 15th round of negotiations for the transatlantic trade and investment partnership (TTIP)
  • EDQM-Chinese Pharmacopoeia Joint Workshop
  • EDQM enhances sharing of information with Japanese regulatory authorities and strengthens collaboration with Japanese Pharmacopoeia
  • Use of a CEP to describe a material used in an application for another CEP
  • Introduction of Office Based RisK Assessments for pharmacy collection sites


  • Submission of Quality Metrics Data 

  • Contract manufacturing arrangements for drugs: Quality Agreements

  • Non-Inferiority Clinical Trials to establish effectiveness

  • Safety Testing of drug metabolites

  • Providing post marketing periodic safety reports in the ICH E2C(R2) format 




  • APIC guidance on aspects of cleaning validation in active pharmaceutical ingredient plants.

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