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Drug registration in Russia, biosimilars registration, fast generic registration, vaccines registration, pharma regulatory service in Russia by CRO Pharegis

Drug Products Registration in Russia

Obtaining registration of a pharmaceutical in Russia is quite a challenge. Both local and international companies that faced Russian drug regulatory system can confirm that.

Formal requirements that are stated in Russian core law “On drug circulation” in many cases are not specific. Understanding of those (and many more) legal paragraphs is critically  important to any company that is planning to register and market their products in Russia.

Russian National Pharmacopeia is quite specific and every product quality control methods should be interpreted according to its requirements and format in official compilation on Russian where no mistake or inaccuracy is allowed. Also, state quality control institutions in Russia in some cases can not perform particular methods described in the original dossier.

Russian regulatory system has unique features like obligatory clinical studies incorporated to a pharmaceutical registration procedure, extensive preclinical studies program for registration and full quality control of first imported batches after registration.

We are quite proud to have full understanding ot every regulatory requirement in its context and practical importance. Pharegis team has more than 50 years of total experience in drug registration in Russia providing full cycle service – from feasibility analysis of particular registration project, dossier gap analysis and registration timeline schedule - to managing preclinical and clinical studies and any quality control questions that can arise.

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 and EAEU

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. 

Drug registration in EAEU (Kazakhstan, Belarus, Armenia, Kyrgyzstan), Uzbekistan, Azerbaijan; regulatory consulting and clinical studies in CIS by CRO Pharegis

Drug Products Registration in Eurasian Economic Union countries, Azerbaijan, Uzbekistan and Georgia

Regulatory systems for medical drugs and medical devices in Russia, Kazakhstan, Belarus, Armenia, Kyrgyzstan as members of Eurasian Economical Union (EEU) were harmonized with implementation of Mutual Recognition and Decentralised Procedures for EAEU country members that is in place since 2016. 

Understanding your business and having experience in EAEU countries as well as Azerbaijan, Uzbekistan and Georgia, 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 compliance procedures, Health authorities requests as well as pharmacovigilance/materiovigilance in those countries that you could focus on high priority projects.