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News & Press: Regulatory Updates

PHSS Regulatory Update August 2015;Fast track routes for medicines,Companies sentenced;EU/Swiss sign

05 August 2015   (0 Comments)
Posted by: Tamsin Marshall
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Introduction

During the last 4 weeks there have been a number of developments in the regulation of the pharmaceutical industry. Sadly we also report on legal actions taken against two UK based companies following supply of defective medicines, one of which resulted in the death of a patient.

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

Europe

  • Fast track routes for medicines that address unmet medical needs
  • EU and Swiss regulators sign confidentiality arrangement
  • Companies sentenced for supplying hospitals with defective pre-filled syringes
  • MHRA Blog – Inspecting clinical trials – the trial master file.
  • MHRA seeking views on draft guidance on re-manufacture of single use devices
  • Verification for authentication of medicines in Europe

USA

  • Request for Quality Metrics
  • Dissolution Testing Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutics
  • Analytical Procedures and Methods Validation for Drugs and Biologics

International

  • National strategy and plan of action for pharmaceutical manufacturing development in Ethiopia (2015–2025)

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