The share of domestic applicants for clinical trials of drugs in Russia has increased, including within the framework of the import substitution program, Deputy Head of the Ministry of Health of Russia Sergey Glagolev said on Friday.
“Despite the fact that some companies now submit fewer applications for [conducting] international multicenter clinical trials, the total volume of clinical trials remains nearly the same. The share of Russian applicants has increased, including as part of the import substitution process, and the trials are not only bioequivalence studies: there are very significant clinical trials, including multicenter ones,” he said at the All-Russian Congress of Patients (quoted by TASS).
When the possible authorization for the use of innovative medicines in Russia based on only completed international trials, without their testing in the Russian Federation, was mentioned, Glagolev said that special conditions should be created for that and certain changes would be made to the legislation.
“The legislation of the Eurasian Economic Union provides for the possibility of registering drugs on the basis of foreign trials, subject to inspection of the data. The corresponding documentation based on the projects of the Ministry of Health is being reviewed by the Eurasian Economic Union, and if it is adopted and if the Ministry of Health of Russia and its subordinate organizations are given the opportunity to inspect foreign clinical sites, then this option can be considered,” the Deputy Minister explained.
At the same time, Glagolev added that the key points in this issue would be whether Russia is willingly accepted abroad as an inspector and whether foreign companies are eager to register their drugs in the Russian Federation.
