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News & Press: Regulatory Updates

PHSS Feb 2017 Regulatory Update: 2016 MHRA GMP symposium; FDA improves foreign inspection program; A

09 February 2017   (0 Comments)
Posted by: Tamsin Marshall
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PHSS February Regulatory Update 2017

 

During the last 4 weeks there have been a number of developments in the regulation of the pharmaceutical industry. This month all reported issues have come from the EU and USA regulatory authorities.

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

 

Europe

  • Tailored scientific advice to support step-by-step development of new biosimilars

  • EMA Management Board: Dec. 2016

  • API-Mix (or mixtures) and CEPs

  • Ph. Eur. Commission concludes its pilot phase for monographs for biotherapeutics still under patent

  • 2015 GMP inspection deficiency data

  • Who inspects the inspectors (part 2)

  • Reducing errors in licence applications

  • 2016 MHRA GMP symposium

  • Control of API supply chain

USA

 

  • FDA improves foreign inspection program, /needs to asses the effectiveness / staffing of foreign offices
  • Non-proprietary naming of Biological Products
  • Proposed New USP General Chapter: The Analytical Procedure Lifecycle <1220>
  • USP 1058 analytical instrument qualification 

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