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News & Press: Regulatory Updates

PHSS Sept 2018 Regulatory Update: Brexit preparedness; Responsible Person named; Quality Attribute c

07 September 2018  
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PHSS Regulatory Update September 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, PIC/S and USA regulatory authorities.

 

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

 

Europe

  • Brexit preparedness: EMA to further temporarily scale back and suspend activities
  • Update on review of recalled valsartan medicines
  • UK government’s preparations for a March 2019 ‘no deal’ scenario.
  • Responsible Person named on the WDA - Part 3
  • What to expect from GPvP inspections

 

USA

  • Dissolution testing and acceptance criteria for immediate-release solid oral dosage form drug products containing high solubility drug substances
  • Elemental impurities in drug products
  • Quality Attribute considerations for chewable tablets


International

 

PIC/s

  • Jordan applies for PIC/S pre-accession

Products

  • New class of drugs fulfills promise of RNA-based medicine
  • FDA approves first generic version of EpiPen
  • Recall of porcine thyroid API from Sichuan Friendly Pharmaceutical Co., Limited, China

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