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News & Press: Regulatory Updates

PHSS Regulatory Update February 2014

17 February 2014  
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. This month reported issues have come from the EU, USA, India & PIC/S regulatory authorities.

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

Europe

  • EudraGMP- Non compliance statements
  • Next steps for the maintenance of information on authorised medicines by marketing-authorisation holders
  • Voluntary parallel scientific advice with NICE and the MHRA

USA

  • Pharmacopeial Forum 39(6) Stimuli to the Revision Process: USP Controlled Room Temperature Range Expansion
  • Pharmacopeial Forum 40(1) Stimuli to the Revision Process: dissolution procedure - development and validation. <1092>
  • FDA Budget approval
International
 
INDIA
  • Process on Good Distrinution practices
PIC/S
  • Revised PIC/S Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments
  • Revised PIC/S GMP Guide

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