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News & Press: Regulatory Updates

PHSS Dec 2019 Regulatory Update: IVMPs new approach; Pharmeuropa 31.4 released; • Review of coumarin

13 December 2019  
Posted by: Tamsin Marshall
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PHSS Regulatory Update December 2019   available for download for members! Login to view


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 and USA regulatory authorities.

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


  •  New approach to extraneous agents testing of immunological veterinary medicinal products (IVMPs)
  • Pharmeuropa 31.4 released
  • Updated Q&A on “Information on nitrosamines for marketing authorisation holders”
  • ‘Regulatory science to 2025’: live broadcast of post-consultation workshop
  • Tripartite meeting held to discuss regulatory approaches for the evaluation of antibacterial agents
  • Regulators' Advice Can Make a Difference: European Medicines Agency Approval of Zynteglo for Beta Thalassemia
  • Dutch Authorities hand over final building to EMA in Amsterdam
  •  EMA Mid-year report 2019
  •  HMA/ EMA task force on Big Data


  • Clinical immunogenicity considerations for biosimilar and interchangeable insulin products
  • Transdermal and topical delivery systems - product development and quality considerations


Australia - Therapeutic Goods Administration (TGA)

  •  Safety review of coumarin in topical listed medicines
  •  Consultation: Draft standards for faecal microbiota transplant (FMT) products

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