The Ministry of Health of the Russian Federation proposed to approve the methodology for calculating fees for clinical trials inspections and pharmaceutical inspections when registering medicines within the framework of good practices of the EAEU. The FSBI Research Center for the Expert Examination of Medical Devices will be responsible for conducting such inspections, FV reports with reference to the draft order on the issue.
“For each type of inspection, the final cost will be determined based on the inspectorate’s estimated costs incurred in connection with the inspections. The typical works are listed with due account for the required labor intensity and labor costs. There are also provisions on the lists of procedures to be performed during the inspection,” the publication writes.
The maximum cost of inspection of clinical and preclinical trials may not exceed 1.6 million rubles in the Russian Federation and 2.1 million rubles in other countries, while the limit for checking the implementation of CAPA plans is 565,000 rubles.