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News & Press: Regulatory Updates

PHSS November 2019 Regulatory Update: EMA type I variations; Tissues and cells for human application

06 November 2019   (0 Comments)
Posted by: Tamsin Marshall
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PHSS Regulatory Update November 2019   available for download for members! Login to view


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 Australian, EU  and USA regulatory authorities.

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


  • New Guide to the quality and safety of tissues and cells for human application
  • EMA encourages companies to submit type I variations for 2019 by end of November 2019
  • European countries increase commitment to responsible antibiotic use in animals
  • EMA Management Board: highlights of October 2019 meeting
  • Dialogue with Chinese authorities on medicine regulation
  • How to ensure that novel analytic methods are fit for decision-making
  • MHRA Process Licensing: useful information
  • MHRA - Digital Health and Pharma 4.0



  • Identification of manufacturing establishments in applications submitted to CBER and CDER – Q&A
  • Drug master files guidance for industry
  • Demonstrating bioequivalence for veterinary soluble powder oral dosage form products or type a medicated articles manufactured from active pharmaceutical ingredients considered to be soluble in aqueous media
  • Drug Products Labeled as Homeopathic




  • TGA Laboratories testing of ranitidine medicines


  • First vaccine to protect against Ebola
  • First non-injectable treatment for severe low blood sugar levels


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