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News & Press: Regulatory Updates

PHSS Aug 2016 Reg Update: Thai FDA accedes to PIC/S ; Revised general cptr on Monocyte-acti test

03 August 2016   (0 Comments)
Posted by: Tamsin Marshall
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PHSS August Regulatory Update 2016

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, PIC/S & WHO regulatory authorities.
The topics covered in this edition of the “Update” include:

 

Europe

  • Revised general chapter on Monocyte-activation test to facilitate reduction in testing on laboratory animals
  • MHRA GxP Data Integrity Definitions and Guidance for Industry

USA

 

  • Updating ANDA labeling after the marketing application for the reference listed drug has been withdrawn
  • Compounded drug products that are essentially copies of a commercially available drug product
  • Periodic Benefit Risk Evaluation Report (PBRER)

International
PIC/S

  • Thai FDA accedes to PIC/S
  • PIC/S Meetings in Manchester (UK) July 2016

WHO

  • International Pharmacopoeia -Proposed revision of the general chapter 1.11 colour of liquids

Products

  • EMA recommends suspension of medicines over flawed studies at Semler Research Centre- Bangalore India

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