Russian pharmaceutical companies are reporting a rise in regulatory barriers when bringing their products to the markets of the Eurasian Economic Union, particularly Kazakhstan and Belarus. This was reported by Kommersant, according to infohub.kz.
Pyotr Rodionov, CEO of the company Geropharm, claims that instead of the mutual recognition procedure for registration dossiers provided for by the regulations, manufacturers are receiving additional requests. As a result, drug registration can be delayed by almost a year.
"Kazakhstan and Belarus are bombarding us with requests outside the regulations, asking things that no one has ever asked before. We go through registration in distant countries — no one there asks such questions," the publication quotes him as saying.
Representatives of Russian relevant agencies also acknowledged difficulties in interaction with Kazakhstan. Sergey Glagolev, Deputy Minister of Health of the Russian Federation, told the publication that the Russian side regularly discusses these issues with Kazakh colleagues at bilateral meetings. According to him, problems arise not only during drug registration but also in setting prices for them and combining lots within government procurement.
In turn, Ekaterina Priezzheva, Deputy Head of the Ministry of Industry and Trade of the Russian Federation, noted that some countries outside the EAEU show greater flexibility. In particular, she mentioned Vietnam and Cuba.
Earlier, Kursiv wrote that the drugs Mounjaro and Wegovy are undergoing accelerated review in Kazakhstan. This was reported by the Ministry of Health, summarizing the results of the digital "single window" for the pharmaceutical market. At that time, it was noted that by early August, 63 contracts had been concluded as part of the accelerated drug review.