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News & Press: Regulatory Updates

PHSS Regulatory Update December 2015 ; Safer use of medicines; Organ-specific warnings;

02 December 2015   (0 Comments)
Posted by: Tamsin Marshall
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PHSS Regulatory Update December 2015

 

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


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


Europe

  • Safer use of medicines by preventing medication errors
  • New strategy to fight antimicrobial resistance
  • Replacement of GCP non-compliant pivotal studies in centralised marketing-authorisation applications not accepted
  • EDQM Free Webinar on Glass containers for pharmaceutical use
  • Optimising the presentation of medicines for Alzheimer's disease
  • Pharmacovigilance inspection report

USA

  • Organ-specific warnings: labelling for OTC products that contain acetaminophen (paracetamol)
  • Formal meetings between the FDA and biosimilar biological product sponsors or applicants
  • Certification Process for Designated Medical Gases

International

PIC/S

  • Croatia (HALMED) joins PIC/S
  • Seminar on biopharmaceuticals - how to inspect



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