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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

Drug registration in Ukraine, Kazakhstan, Belarus, Uzbekistan, Azerbaijan; regulatory consulting and clinical studies in CIS by CRO Pharegis

Registration of pharmaceuticals in EEU countries, Ukraine and Georgia

Regulatory systems for medical drugs and medical devices in Russia, Kazakhstan, Belarus, Armenia, Kyrgyzstan as members of Eurasian Economical Union (EEU) are expected to be changed with implementation of Mutual Recognition Procedure for EEU country members that will be actual already in 2016. 

Understanding your business and having experience in EEU (CIS) countries as well as Georgia and Ukraine, we can handle your registration activities to plan and minimize timeline for getting access to those countries’ promising markets.

Also we can handle communication activities regarding post-registration quality issues, Health authorities requests as well as pharmacovigilance/materiovigilance in those countries that you could focus on high priority projects.

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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