Vladislav Shestakov Moderated Plenary Discussion on Traceability System Implementation at Pharmtech & Ingredients Exhibition

    On November 27, within the framework of the international exhibition “Pharmtech & Ingredients,” a plenary session titled “Traceability of API Origin: From Pilot to Common Practice in the EAEU” was held. The discussion was moderated by Vladislav Shestakov, Director of the Federal State Budgetary Institution “State Institute of Medicines and Good Practices” (FSBI “SID & GP”).

The session featured presentations by industry experts and representatives of pharmaceutical companies: Maria Borzova, Legal Advisor of the Association of Pharmaceutical Manufacturers of the EAEU; Evgenia Shapiro, General Director of PSK Pharma; Filipp Romanov, General Director of the Lekmedobrashcheniye Association; Egor Zhavoronkov, Head of the Socially Significant Goods Department at CRPT; Lyudmila Shcherbakova, President of Velfarm Company; and Sergey Avdeenko, Head of Government Relations at Promomed.

Participants discussed key aspects of implementing the traceability system for active pharmaceutical ingredients (APIs), including assessing the industry’s current readiness for the transition, the status of the regulatory framework, minimizing the administrative burden on businesses, technological solutions to facilitate system implementation, and the impact of these innovations on drug affordability and achieving pharmaceutical sovereignty.

The pilot project for implementing the traceability system for active pharmaceutical ingredients was launched in the Russian Federation in 2023. Its primary objective is to verify the actual country of origin of APIs and, consequently, the depth of localization of drug production within Russia and EAEU countries.

In his concluding remarks, Vladislav Shestakov emphasized: “Traceability of substance origins is not merely a control tool but also a crucial step towards enhancing supply chain transparency, strengthening technological sovereignty, and building trust in the quality of domestic medicines. The successful implementation of this initiative in 2026 depends on how coordinated our efforts are in addressing regulatory, technological, and organizational aspects.”

Holding such expert discussions helps establish unified, coordinated approaches within the industry, aimed at successfully achieving strategic objectives for the development of the pharmaceutical industry in the Russian Federation and across the EAEU region.