The dietary supplement market in Russia is gradually moving toward stricter evidence-based standards. Following the introduction of new requirements for substantiating the effectiveness of dietary supplements, the topic of clinical studies has become especially relevant.

The Russian market for dietary supplements (DS) is transitioning to new regulatory requirements. By Resolution No. 398 of the Government of the Russian Federation dated April 13, 2026, criteria for the quality and efficacy of dietary supplements, as well as requirements for substantiating their claimed properties, have been approved.

The development of a new medicinal product is a complex and costly process in which clinical trials play a critical role in confirming the efficacy and safety of a therapy.

Clinical trials in Russia in 2026 remain one of the most expensive stages in bringing a new pharmaceutical product or medical device to market. At the same time, project costs may vary by dozens of times — from several million rubles for a local bioequivalence study to hundreds of millions or even billions of rubles for international multicenter Phase III programs.

Clinical trials in Russia in 2026 remain one of the most expensive stages in bringing a new pharmaceutical product or medical device to market. At the same time, project costs may vary by dozens of times — from several million rubles for a local bioequiva