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News & Press: Regulatory Updates

PHSS Feb 2019 Reg Update: EMA relocation update; FDA’s ongoing investigation into valsartan and ARB

14 February 2019   (0 Comments)
Posted by: Tamsin Marshall
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PHSS Regulatory Update Feb 2019 available for download for members! Login to view.


During the last 4 weeks despite, or perhaps because of preoccupation with Brexit and EMA relocation plus US Government shutdown, there have been a number of developments in the regulation of the pharmaceutical industry. This month reported issues have come from the EU and Swiss, USA and WHO regulatory authorities. (Readers should perhaps particularly note the FDA Commissioners concerns and comments about solvent recovery systems (see valsartan / ARB impurities); this is liable to become a point of focus for inspectorates worldwide.MH)

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




  • EMA relocation updates
  • Overview of comments received on ICH guideline Q12
  • Revised guideline - global approach to development of new antibacterial medicines
  • EMA Regulatory Science to 2025  -strategic reflection
  • UK government preparations in event of a No Deal Brexit
  • Further guidance note on the regulation of medicines, medical devices and clinical trials if there's no Brexit deal



  • FDA’s ongoing investigation into valsartan and ARB class impurities
  • ANDA submissions – amendments and requests for final approval to tentatively approved ANDAs
  • Immunogenicity Testing of therapeutic protein products —developing and validating assays for anti-drug antibody detection
  • Labeling for human prescription drug and biological products approved under the accelerated approval regulatory pathway
  • REMS assessment: planning and reporting
  • Survey Methodologies to assess REMS goals that relate to knowledge




  • Guidance document GMP compliance by foreign manufacturers (HMV4)


World Health Organization (WHO)

  • Guidance on testing of “suspect” falsified medicines

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