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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

Pharmaceutical variations registration type Ia type Ib type II CMC SmPC and safety variations drug renewal service in Russia by regulatory service CRO Pharegis

Registration of dossier variations (type Ia, type Ib and type II) in Russia

is quite different from EU or US procedures. Before 2010 dossier variations were relatively simple procedure.

Currently Russian regulatory requirements for variations propose different types of variations, some of them can require quality control expertise, local clinical study or even both.

Our team has experience since 1999 in registration of pharmaceutical variations namely:

  1. Changes in composition,
  2. Adding new pharmaceutical form with similar composition
  3. Adding new dosage
  4. Adding new packaging,
  5. Adding new indications,
  6. SmPC text harmonization,
  7. SmPC urgent safety updates,
  8. Adding of new quality control methods,
  9. Change of quality control methods,
  10. Change of packaging or marking,
  11. Addition of new manufacturer,
  12. Change of storage conditions,
  13. Extension of shelf life
  14. Others

We provide full cycle service of timely registration of all kinds of pharmaceutical variations as well as consultation on optimal strategy of registration of a particular variation - whether it requires immediate registration in Russia or can be postponed and cumulated with upcoming dossier variations. MoH approval of some types of variations is not obligatory. 

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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