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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.
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:
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.
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.