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News & Press: Regulatory Updates

PHSS Sept 2019 Regulatory Update: Q&A Imported ATMPs; Sartan Medicines; HHS Announcement

03 September 2019  
Posted by: Tamsin Marshall
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PHSS Regulatory Update September 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 USA and EU regulatory authorities.

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



  • Q&A on the exemption from batch controls carried out on ATMPs imported into the European Union from a third country.
  • Sartan medicines: companies to review manufacturing processes to avoid presence of nitrosamine impurities
  • Temporary interim limits for NMBA, DIPNA and EIPNA impurities in sartan blood pressure medicines
  • EMA/FDA analysis shows high degree of alignment in marketing application decisions between EU and USA
  • MHRA Falsified Medicines and the supply chain (part 2)
  • MHRA Analytical Quality by Design (AQbD): Q&A


  • HHS announces new action plan to lay foundation for safe importation of certain prescription drugs
  • Child-Resistant Packaging statements in drug product labeling
  • Information about immune globulin (human) product shortage
  • Regulatory harmonization and convergence
  • Biological Product and HCT/P deviation reports  annual summary for fiscal year 2018
  • Oncology therapeutic radiopharmaceuticals:  nonclinical studies and labeling recommendations
  • Patent certifications and suitability petitions (ANDAs)



  • TGA actions following 2018 stakeholder surveys
  • Mandatory information required in advertising for therapeutic goods


  • Swissmedic laboratory publishes updated test method for nitrosamines in sartans


  • Names of liposomal medicines to be changed to avoid medication errors

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