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News & Press: News

PHSS July 2018 Regulatory Update: Shortages of Medicines; Q12 Technical and Regulatory Consideration

12 July 2018   (0 Comments)
Posted by: Tamsin Marshall
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PHSS Regulatory Update July 2018


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  and PIC/s regulatory authorities plus ICH.

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



  • Shortages of Medicines
  • EDQM publishes a new section dedicated to biotherapeutics on its website
  • New EDQM guieline "How to read a CEP"
  • Updated Q+As and practical guidance for pharmaceutical companies to prepare for UK's withdrawal from EU
  • Q&A on the impact of the MRA between the EU and the USA
  • Two more EU Member States benefit from EU-US mutual recognition agreement for inspections
  • The Responsible Person named on the WDA.



  • Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
  • Development of a Shared System REMS
  • Waivers of the Single, Shared System REMS Requirement
  • Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products
  • Medical Product Communications That Are Consistent With the FDA-Required Labeling — Q & A
  • Human food safety of new animal drugs used in food-producing animals



  • Half yearly performance snapshot: July to December 2017
  • Biologicals regulatory framework proposed changes
  • Management and Communication of Medicines shortages




  • New ICH Guidelines Q13 & Q14



  • New PIC/S Guidance Documents


  • First two marketing authorisations for chimeric antigen receptors (CAR) T-cell therapies in the EU
  • First stem cell-based veterinary medicine recommended for EU marketing authorisation
  • Hydroxyethyl starch solutions: new measures to protect patients


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