Review of the documents necessary of the approval of a clinical trial of a medicinal product for human use, forming of an expert opinion on the possibility or the impossibility of such a clinical trial and submission of this opinion to the Ministry is performed within 30 workdays following the receipt of the Ministry’s task by the expert institution, with the following documents attached:

1. a non-clinical study report, including description, results, and statistical analysis of the results obtained;

2. draft protocol of a clinical trial;

3. investigator’s brochure;

4. reports of clinical trials, bioequivalence and/or therapeutic bioequivalence studies of the product conducted in applicant's country and other countries (including epidemiologic studies of immunobiological products for immunological prevention and therapy of infectious diseases, including those of children) with description of performed studies of the product, results thereof, and statistical analysis of obtained results (at the applicant’s discretion).

5. document proving payment of state fee for expert evaluation for approval of a clinical trial and ethic review upon the application for drug authorization.

Source:

Order of Russian MoH No. 750н dated 26.08.2010 Regulations on Expert Evaluation of Drug Products for Human Use and Forms of Expert Opinions on the Results of the Evaluation

Federal Law No. 306-ФЗ dated 27.11.2010 On amendments to Parts 1 and 2 of the Internal Revenue Code of the Russian Federation and Russian Federal Law "On tax authorities of the Russian Federation"

Federal Law N 41-ФЗ dated 05.04.2010