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News & Press: Regulatory Updates

PHSS August 2019 Regulatory Update: EU / US MRA fully operational; Medicine shortages; CDER Ann Rep

06 August 2019   (0 Comments)
Posted by: Tamsin Marshall
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PHSS Regulatory Update August 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:



  • EU / US MRA fully operational
  • Medicine shortages: EU network takes steps to improve reporting and communication
  • Call for all sponsors to publish clinical trial results in EU database
  • EMA takes note of the European Ombudsman’s decision on pre-submission activities
  • MHRA Blog - How the implementation of Safety Features progresses 5 months in
  • UK government - Development of new antibiotics encouraged with new pharmaceutical payment system
  • BP and USP formalize partnership to strengthen quality of medicines and public health




  • CDER office of compliance Annual report FY 2018
  • Instructions for use — content and format
  • Drug Abuse and Dependence section of labeling for human prescription drug and biological products
  • REMS Modifications and revisions guidance for industry
  • Using the Inactive Ingredient Database
  • Cell analysis technique identifies subpopulations of stimulated mesenchymal stromal cells with in vitro immunosuppressive activity
  • Harmonizing compendial standards with drug application approval using the USP pending monograph process guidance for industry



  • TGA strengthens regulation of stem cell treatments
  • Remaking Therapeutic Goods Order No. 78 – (tablets /capsules/pills)




  • Rituzena Withdrawal of the marketing authorisation in the European Union

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