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News & Press: Regulatory Updates

PHSS June 2019 Regulatory Update:EP 10th Edition 10.0-10.2; EDQM inspections

03 June 2019   (0 Comments)
Posted by: Tamsin Marshall
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PHSS June 2019 Regulatory Update


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 Australian and USA regulatory authorities.

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



  • EMA facilitates early engagement with medicine developers to combat antimicrobial resistance

    European Pharmacopeia 10th Edition 10.0-10.2

  • EDQM inspections and trends of GMP deficiencies: Overview 2006 to 2018

  • What does qualification of suppliers mean to you? Risks to patients and to your business




  • Considerations in demonstrating interchangeability with a reference product
  • Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations
  • Submitting documents using real-world data and real-world evidence to FDA for drugs and biologics
  • Framework for the Regulation of Regenerative Medicine Products



  • Medicine Shortages in Australia: Reporting obligations and the TGA's compliance framework



  • Changes regulations to help prevent illegal production and trafficking of controlled substances


  • PIC/S meeting April 2019 (Geneva Switzerland)


  • The 53rd ECSPP report (WHO Technical Report Series, No. 1019) now available 


  • EU withdrawal of marketing authorisations for fenspiride medicines
  • EU Restrictions in use of Xeljanz while EMA reviews risk of blood clots in lungs

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