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.