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News & Press: Regulatory Updates

PHSS August 2020 Regulatory Update: Action Plan on ATMPs; EMA final opinion nitrosamines; FDA new RA

04 August 2020   (0 Comments)
Posted by: Tamsin Marshall
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PHSS Regulatory Update August 2020available 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 Australian, EU, UK and USA regulatory authorities.
The topics covered in this edition of the “Update” include:

  • Action Plan on ATMPs
  • EDQM Highlights – 2019 annual report
  • EMA finalises opinion on presence of nitrosamines in medicines
  • ICH guideline M7 assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk – Q&A Step 2b 
  • Guideline on the quality of water for pharmaceutical use
  • EMA Annual activity report 2019
  • Implementation of the new Veterinary Medicines Regulation
  • European medicines agencies network strategy to 2025
  • Joint Audit Programme for EEA GMP inspectorates
  • MHRA planning for return to on-site Good Practice (GxP) inspections
  • MHRA A Practical example of applying Quality Risk Management in GDP – Transportation Risks



  • FDA prepares for resumption of domestic inspections with new risk assessment system
  • Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products
  • Setting endotoxin limits during development of investigational oncology drugs and biological products 


Therapeutic Goods Administration (TGA) 

  • GMP approach to overseas manufacturers of medicines and biologicals during the COVID-19 pandemic
  • TGA expectations for overseas manufacturing sites hosting remote inspections during the COVID-19 pandemic
  • Consultation on the new Therapeutic Goods Order 106 - Data matrix codes and serialisation of medicines 

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