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PHSS Regulatory Update October 2015: EC, EMA and WHO cooperation to protect global health

07 October 2015   (0 Comments)
Posted by: Tamsin Marshall
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PHSS Regulatory Update October 2015


During the last 4 weeks there have been a number of developments in the regulation of the pharmaceutical industry. This month we have reported issues that have come from the EU, PIC/S and USA regulatory authorities.

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


  • EC, EMA and WHO step up cooperation to better protect global public health
  • Implementing Act on Principles and guidelines on GMP for medicinal products for human use
  • CEP – Content of the dossier for chemical purity and microbiological quality
  • Ph. Eur. Elemental Impurities: Clarification for products outside the scope of the ICH Q3D Guideline
  • EDQM releases new edition of Technical Guide for the Elaboration of Monographs


  • Formal Dispute Resolution: Appeals Above the Division Level
  • Q3D Elemental Impurities
  • Nonproprietary Naming of Biological Products-



  • Revision of PIC/S GMP Guide
  • 2015 PIC/S Seminar, Indonesia


  • CE certificate for all medical devices made by Brazilian manufacturer Silimed suspended.
  • Re-scheduling of Codeine products (Australia)
  • EMA fast-tracks antidote to anticoagulant Pradaxa
  • New EU guidance to speed up development of antibiotics

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