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News & Press: Regulatory Updates

PHSS Nov 2018 Reg Update: Safety Features for medicinal prods for human use; FDA on angiotensin

14 November 2018   (0 Comments)
Posted by: Tamsin Marshall
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PHSS Regulatory Update November 2018


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, PIC/S and USA regulatory authorities.


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



  • Safety Features for medicinal products for human use Q&A V11

  • Cross-contamination control and Health Based Exposure Limits (HBEL) Q&As

  • MHRA Inspectorate staff changes

  •  e-consent



  • FDA updates on angiotensin II receptor blocker (ARB) recalls

  • Selection of the appropriate package type terms and recommendations for labeling injectable medical products

  • M9 biopharmaceutics classification system-based biowaivers

  • Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs

  • Assessing adhesion with transdermal and topical delivery systems for ANDAs

  • Assessing the irritation and sensitization potential of transdermal and topical delivery systems for ANDAs 




  • TGA business plan 2018-2019
  • TGO 98 Microbiological Standards for Medicines (2018)



  • PIC/s meeting in Chicago (USA)

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