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News & Press: Regulatory Updates

PHSS May Regulatory Update: Noval Therapies; OBERA; When is a REMS Neccessary

14 May 2019  
Posted by: Tamsin Marshall
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PHSS Regulatory Update May 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 EU Australian and USA regulatory authorities.

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



  • The role of regulators in establishing added benefit of novel therapies
  • MHRA - GDP Office Based Evaluation and Risk Assessment programme (OBERA)




  • Application of statutory factors in determining when a REMS is necessary
  • Bispecific antibody development programs
  • CBER FY 2018 Report
  • FDA updates on angiotensin II receptor blocker (ARB) recalls including valsartan, losartan and irbesartan
  • Special 301 Report on Intellectual Property Protection and Review of Notorius Markets for Piracy and Counterfeiting




  • Guidance for TGO 101 – (Standard for tablets, capsules and pills
  • Standard for Disinfectants and Sterilants (TGO 54 / TGO 104). - Outcomes from consultation



  • Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic USA Stockpiles 

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