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Our news

  • 18/07/2019: Pharegis implemented optimized procedures for state registration of pharmaceuticals in Eurasian Economic Union.
  • 20/06/2019: Pharegis updated timelines and practical approaches for Russian and EEU GMP inspection applications and procedures.
  • 03/04/2019:  Renewed general monographs of Russian state pharmacopeia XIV ed. have been analyzed.

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Regulatory Events Russia

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Russian Regulatory News

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News and press releases

  • New measures to avoid potentially fatal dosing errors with methotrexate for inflammatory diseases, CHMP, 23/08/2019
  • EMA/FDA analysis shows high degree of alignment in marketing application decisions between EU and US, , 16/08/2019
  • EMA closed 15 August 2019 , , 13/08/2019
  • Supporting medicine developers in generating quality data packages in early access approaches (PRIME and breakthrough therapies): workshop report published , , 31/07/2019