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News & Press: Regulatory Updates

PHSS March 2016 Regulatory Update :Deleg Reg 2016/161; Rev EP Raman Spect; CA) for Type II API DMFs

03 March 2016   (0 Comments)
Posted by: Tamsin Marshall
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PHSS March Regulatory Update 2016


This month reported issues have come from the EU and USA regulatory authorities.

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


  • Pharmacopoeial Discussion Group (PDG)  November 2015
  • European Formulary for paediatric medicines
  • Revised European Pharmacopoeia (EP) General Chapter on Raman Spectroscopy
  • High performance thin-layer chromatography (HPTLC) of herbal drugs and herbal drug preparations
  • Delegated Regulation 2016/161
  • Delegated Regulation 2016/161 (Applicability to UK)
  • First year’s work of the UK stakeholders' reclassification platform
  • Improvements to the change of ownership application (COA) process for medicines marketing authorisations (MA).


  • Completeness assessments (CA) for Type II API DMFs under GDUFA
  • Characterization of ultrahigh molecular Weight polyethylene (UHMWPE) used in Orthopedic devices
  • Recommendations to reduce the risk for Zika virus blood transmission in USA
  • Immunogenicity-related considerations for low molecular weight heparin



  • New toolkit supports better understanding of the risks of valproate and pregnancy
  • FDA Advisory Committee recommends approval of first biosimilar monoclonal antibody (mAb) medication
  • Fusafungine nose and mouth sprays are no longer marketed in the EU

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