Section: "How Chinese Pharmaceutical Companies Can Work Effectively and Safely with Russia in 2025–2030"

The second part of the Russian-Chinese session was devoted to practical issues of Chinese pharmaceutical companies entering the Russian market. Anastasia Valova, Managing Partner of SINORUSS, continued as moderator.

In her report "Entry of Chinese Pharmaceutical Companies into the Russian Market: Legal Aspects and Practical Recommendations," Anastasia Valova emphasized that a typical mistake is starting to prepare a registration dossier without conducting a market analysis. The first step is an independent assessment of competition, procurement volumes, and real product demand. Registration under EAEU rules remains a complex examination of quality, clinical and preclinical data, and the possession of a GMP certificate does not exempt a manufacturing site from inspection by the Russian regulator. The report also examined mandatory digital labeling, financial settlements, and logistics, which are critical when working with government procurement. Among the entry models, the speaker identified independent registration, working through a partner, and localization, emphasizing the need for a systematic and step‑by‑step approach.

Regulatory specifics of medical devices were presented by Nadezhda Vorobyeva, Head of Clinical Trials for Medical Devices at Alikvota LLC, in her report "Features of Registration of In Vitro Diagnostic Medical Devices Using the Example of Medical Devices from Chinese Manufacturers." The structure of the registration dossier, requirements for clinical trials, the procedure for inspecting manufacturing sites, and typical errors in document preparation were discussed.

A logistics perspective was presented by Alexandra Gerasimova, Head of Sales for the Pharmaceutical Sector at WELLGO, with the topic "Peculiarities of Pharmaceutical Logistics from China." The speaker noted the growth in shipments of pharmaceutical substances from China and the key challenges: maintaining temperature conditions, supply chain transparency, and infrastructure readiness for increased volumes. The company's approach is based on transport quality control and the use of a pharmaceutical warehouse in Shanghai for additional cargo inspection.

The session was concluded by Vladislav Shiyanov, Head of Pharmaceutical, Medicine, and Biotechnology Practice at Nextons, with the report "Effective Models for Foreign Pharmaceutical Companies' Presence in Russia: Time‑Tested Examples." He identified four factors for model selection: sales channel, asset control, stability of settlements and logistics, and investment horizon. The distributor model is effective for quick entry; localization opens access to government procurement; however, hybrid structures are becoming the most sustainable today.

Based on the discussion outcomes, participants noted that despite all the barriers — from cross‑border payments to regulatory differences — a systematic approach and a well‑chosen model of presence allow Chinese companies to build long‑term operations in the Russian pharmaceutical market.