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News & Press: Regulatory Updates

PHSS Regulatory Update July 2014

08 July 2014  
Posted by: Tamsin Marshall
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PHSS Regulatory Update July 2014

Introduction

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

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

Europe

  • Qualified Person’s declaration concerning GMP compliance of the active substance manufacture
  • European pharmacopoeia (EP)-First draft finished product monograph with chemically defined active substance published for comment
  • Use of a CEP for a starting material in an application for a CEP

  • EDQM signs confidentiality agreement with Taiwan FDA (TFDA)
  • Generic medicine quality Forum

USA

  • Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines and Related Recombinant Viral or Microbial Products

  • Q4B Annex 6 Uniformity of Dosage Units General Chapter
  • Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification
  • Guidance for Industry: Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels

  • Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologics

India

  •  Track and trace requirements delayed for primary packaging of exported product

Products

  • Cancer drug docetaxel
  • Update on investigation into Bacillus cereus infections (MHRA)

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