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News & Press: Regulatory Updates

PHSS Regulatory Update February 2015

03 February 2015   (0 Comments)
Posted by: Tamsin Marshall
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PHSS Regulatory Update February 2015   

INTRODUCTION

During the last 4 weeks there have been a number of developments in the regulation of the pharmaceutical industry. This month a number of important product issues are also noted.

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

Europe

  • 3 PhEur monographs suppressed
  • MHRA GMP data integrity definitions and guidance for industry
  • MHRA Devices Online Registration System (DORS)
  • MHRA helps pharmaceutical companies develop European (UK) innovative technology sites

 

USA

  • Launch of office of pharmaceutical quality
  • New & revised draft guidances CDER is planning to publish during calendar year 2015
  • Draft Guidance for Industry -CGMP requirements for combination products

 

International

ICH

  • ICH Q3D Guideline on Elemental Impurities

 

PIC/S

  • Mexico applies for PIC/S membership

 

Products

  • UK recall of oral diclofenac presentations with legal status ‘P’
  • FDA’s investigation into patients being injected with simulated IV fluids continues
  • Determination that Tagamet (cimetidine) tablets and other drug products were not withdrawn from sale for reasons of safety or effectiveness
  • GVK Biosciences Hyderabad: EMA recommends suspending medicines over flawed studies
  • Stronger advice on the use of valproate medicines in women

 

Documents

  • New Orange and Green Guides 2015

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