This website uses cookies to store information on your computer. Some of these cookies are used for visitor analysis, others are essential to making our site function properly and improve the user experience. By using this site, you consent to the placement of these cookies. Click Accept to consent and dismiss this message or Deny to leave this website. Read our Privacy Statement for more.
Print Page   |   Contact Us   |   Sign In   |   Register
News & Press: Regulatory Updates

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

07 September 2018  
Share |

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

Membership Software Powered by YourMembership  ::  Legal