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PHSS June 2017 Regulatory Update ;Reporting irregularities; Brexit - Notice to marketing

05 June 2017   (0 Comments)
Posted by: Tamsin Marshall
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PHSS Regulatory Update June 2017


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 and East African regulatory authorities.

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



  • Brexit - Notice to marketing authorisation holders of centrally authorised medicinal products.
  • Q&A-UK withdrawal from EU-medicinal products within the framework of the Centralised Procedure
  • Reporting irregularities that may affect medicines
  • Increasing understanding of biosimilar medicines – new guide
  • New EudraVigilance system for collection and monitoring of suspected adverse reactions
  • MHRA inspectorate organogram.




  • Burkholderia cepacia complex poses a contamination risk in non-sterile, water-based drug products
  • USP general chapters <659>, <661.1> <661.2> Packaging and Storage Requirements
  • USP new and revised draft Chapters on Elastomeric Closures <381>, <382>, <1381> and <1382>.
  • Modernizing the way drugs are made: a transition to continuous manufacturing
  • Use of Nucleic Acid tests to reduce the risk of transmission of West Nile Virus from living donors.


East African Community (EAC)

  • EAC looks to EMA as model for future regional agency


  • EMA recommends changes to prescribing information for vancomycin antibiotics
  • FDA approves first cancer treatment for any solid tumor with a specific genetic feature


  • EMA 2016 annual report



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