The pharmaceutical industry in the Russian Federation is steadily growing its output. At the same time, it is extremely important that Russian advanced developments reach patients more quickly.

«We are currently observing a consistent position of the state aimed at promoting the innovative development of the Russian pharmaceutical industry.

The pharmaceutical industry has long been asking to draw attention to the need for the government to take support measures regarding the conduct of early‑stage clinical trials.” The development and production of novel drugs require significant investment and time. Therefore, along with funding phase 3 of clinical trials, we consider it important and logical for the Ministry of Industry and Trade to announce the next step — support for phases 1 and 2 of clinical trials, which essentially determine the future of new medicinal products. Involving manufacturers and the scientific community in a dialogue with the regulator on this issue will help to develop the most appropriate solution that accommodates the industry’s needs,” Dmitry Zaitsev believes.

According to him, financial measures that stimulate the development of innovation should work in conjunction with regulatory mechanisms. The mandatory pre‑registration scientific consultation procedure will help companies who are starting new clinical trials avoid possible mistakes at the drug development stage and reduce time and financial costs. “Both last year and this year, we have also talked a lot about scientific advisory process. The adoption of the relevant draft law on scientific consultations by an authorized body will be an important and correct measure that will help innovations reach the registration stage more quickly, rather than make it slide back,” the CEO of JSC “Pharmstandard” noted at the round table hosted by the Kommersant Publishing House, “Innovations in the Russian pharmaceutical industry: breakthrough or utopia?”

Another important issue facing the industry is the full implementation of the accelerated registration rules (fast tracks) and the launch of breakthrough innovative drugs into the market. As an example, Dmitry Zaitsev cited the situation with the verenofuz‑alpha drug: registered in 2025, submitted for the inclusion into the essential drugs and high cost nosologies lists, while the drug will reach Russian patients only in 2028–2029.

“The loss of 3–4 years represents an unacceptable delay for Russia’s leading‑edge developments,” notes Dmitry Zaitsev. He believes that broader implementation of the mechanism for the expedited registration of innovative medicines—as provided for in Clause 9.1 of Government Resolution No. 871—would significantly shorten the time to patient access in Russia.