Obligatory clinical trials for registration of medicines in Russia

As you know well, Russia has its own procedures for registration of new medicines. One of those national features is registration clinical studies. Every drug product to be registered in Russia should pass local clinical study for its safety and efficacy (under GCP), unless its efficacy and safety had already been studied in multinational clinical study with participation of at least two centers in Russia.

Registration clinical studies

are not required only for very limited groups of medicines like locally confirmed orphan drugs (by separate regulatory procedure according to last amendment to the Drug Law in Russia since July 2015) or generic products having their full registered analogs on the Russian market for more than 20 years.

Clinical trials for registration of original product or biosimilar product in Russia

require extensive clinical study program that includes local phase I, phase II and limited phase III (the latter two phases can be combined into one clinical study in some cases).

Registration clinical studies for generic drugs

imply either conduction of a bioequivalence clinical study on limited number of healthy volunteers (in some cases – patients) or therapeutic equivalence study depending on drug formulation and Russian MoH guidelines for bioequivalence studies.

Requirements for conduction of a clinical study in Russia

are typical: Clinical Study Protocol, Case Report Form template (CRF), Investigator Brochure, Patient information leaflet with Patient consent form as well as Life and Health Insurance for subjects in Russia should be prepared in Russian language according to MoH official guidelines and National GCP standard.

And for any clinical study project  one should get optimal balance between official Russian regulatory requirements, specifics and possibilities of the clinical centers and patients on the one hand, and your business focus, priorities and market forecast, on the other.

You can contact us sending your request to to get fast and free feasibility assessment and calculation of the study budget and timeline. Thanks to our consultants and regulatory experts you will be able to discuss your project in detail for free - to get working solution and understanding of optimal perspective for your project.