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News & Press: Regulatory Updates

PHSS Jan 2017 Regulatory Update; Guidelines Chemistry of active substances and Elec subm on CE appli

26 January 2017   (0 Comments)
Posted by: Tamsin Marshall
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PHSS January Regulatory Update 2017


Welcome to the 1st regulatory update of 2017. 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,USA,ICH and PIC/s

Once again it is of concern that we report on a recall of all products from a USA compounding pharmacy on the grounds of lack of sterility assurance. (see products section)

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



  • Guideline on the chemistry of active substances
  • EP commission adopts the monograph on sodium pertechnetate (99mtc) (accelerator-produced) injection (2891)
  • Measures to reduce animal testing
  • Guidance and roadmap for electronic submissions for CEP applications
  • 2016 MHRA Laboratories Symposium Q&A


  • Drug Supply Chain Security Act Implementation: Identification of suspect product and notification
  • Clinical pharmacology data to support a demonstration of biosimilarity to a reference product.



  • ICHQ11 Q&As


  • Letter of Agreement with the EEA HMA (Heads of Medicines Agencies)
  • Revision of PIC/S GMP Guide


  • Tri-Coast Pharmacy Inc. Voluntarily Recalling All Sterile Products Prepared May 17, 2016 - Nov 17, 2016


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