FSI SID&GP | Results of the X All-Russian GMP Conference with International Participation Summarized

Results of the X All-Russian GMP Conference with International Participation Summarized

X All-Russian GMP Conference has been organized since 2016 by the Ministry of Industry and Trade of the Russian Federation jointly with the Federal State Budgetary Institution “State Institute of Medicinal Products and Good Practices” (FSI “SID & GP”). This year, experts from more than 30 countries joined the event, including states of the EAEU, Asia, Africa, the Middle East, and Latin America.

Among speakers of the Plenary Session on the topic “Pharmaceutical Industry – Uniting Efforts for Patient Health” were: Anton Alikhanov, Minister of Industry and Trade of the Russian Federation; Mikhail Murashko, Minister of Health of the Russian Federation; Maxim Uvaidov, State Secretary – Deputy Minister of Agriculture of the Russian Federation; Anatoly Garbuzov, Minister of the Moscow City Government, Head of the Department of Investment and Industrial Policy of Moscow; Alexey Repik, Chairman of the All-Russian Public Organization “Business Russia”; and Vsevolod Tkachuk, Acting Director of the Medical Research and Educational Institute of Lomonosov Moscow State University. The session was moderated by Vladislav Shestakov, Director of the FSI “SID & GP”.

“The pharmaceutical industry is actively growing: about 80 industrial pharmaceutical sites and facilities have opened in the country over the past 15 years, production volume has increased 6-fold, the share of products from Russian manufacturers has almost doubled – reaching 41% in value terms and 64% in physical terms. There are quite a number of license holders – over five hundred,” said Anton Alikhanov, Head of the Russian Ministry of Industry and Trade.*

Common EAEU Medicines Market: Globalization and Convergence of Approaches

The agreement on common principles and rules for the circulation of medicinal products in the EAEU was signed in 2014, and significant progress has been made in its regulation and the convergence of practices over the past 10 years. These issues were discussed at the conference by more than 10 representatives of regulatory authorities from EAEU member states and the Eurasian Economic Commission.

Dmitry Galkin, Director of the Department for Pharmaceutical and Medical Industry Development of the Russian Ministry of Industry and Trade, noted that in the context of active globalization processes in the pharmaceutical industry, approaches to ensuring and controlling product quality are necessarily taken into account.

“Various stages of development, research, production, and market release are often carried out in countries with different regulatory systems and approaches. For instance, multi-stage production chains, sometimes involving several manufacturing sites in different countries contributing to the release of a single drug subsequently supplied to several markets, lead to the necessity of complying with various regulatory requirements. The globalization of the medicines market makes the convergence of regulatory standards and approaches for various stages of the medicinal product life cycle essential,” said Dmitry Galkin.

The goal of this work is to create common regulatory frameworks, increase drug accessibility, and enhance the coherence of related approaches so that every patient within the Union is equally confident of receiving a high-quality, effective, and safe medicine.

Quality control of medicines begins at the stage of production facility design and obtaining permits. Elena Denisova, Deputy Director of the Department for Pharmaceutical and Medical Industry Development of the Russian Ministry of Industry and Trade, spoke about the production licensing system.

“EAEU Rules stipulate that the production of medicinal products throughout the Eurasian economic space is carried out in accordance with GMP Rules on the basis of a permit, or license, issued in accordance with the legislation of the member states. The licensing institute is an instrument of state regulation that contributes to the civilized development of the pharmaceutical industry and prevents harm to the rights, legal interests, life, or health of citizens,” explained Elena Denisova.

Practical Experience and Dialogue with Manufacturers

Practical experience was discussed jointly by regulators and pharmaceutical manufacturers. For example, Roman Karasev, Quality Director at Gedeon Richter-Rus, shared the company’s practical experience in implementing a project approach when preparing for the licensing of a pharmaceutical enterprise, which covers all structural divisions. Among the success factors that allow organizing preparation as a structured, predictable, and manageable process with clear goals, deadlines, and personal responsibility, he named early planning, team competence, data quality, as well as proactive communication and constant dialogue with all process participants, including regulatory authorities.

The session dedicated to the activities of microbiological laboratories at pharmaceutical manufacturing sites discussed the study of microorganisms to ensure product safety and quality.

Evgenia Yakusheva, Head of the Microbiological Laboratory of the Quality Control Department at “Velfarm-M”, spoke about controlling the risk of endotoxin contamination using the example of a specific drug produced at the manufacturing site in Zelenograd. Bacterial endotoxins pose a serious threat to the production of sterile medicinal products, making it crucial to constantly monitor and control the main sources of contamination, apply risk minimization strategies, and special control methods.

According to industry representatives, the dialogue between regulators and manufacturers at the GMP conference platform contributes to the development of the industry. This was noted, in particular, by Tatiana Vyazmina, Quality Director at R-Pharm Group.

“The GMP conference is a platform where new benchmarks are set, best practices are discussed, and the initiatives that directly influence the development and improvement of quality systems are born. Here, participants can openly exchange opinions, debate, define, and adjust approaches to implementing specific requirements of Good Practices, making the dialogue truly valuable. This confirms once again that the conference involves highly committed, top-level experts, and it is they, together with the regulators, who determine the vector for the development of quality systems. Such discussions help perfect processes at enterprises and ultimately ensure patients receive effective and safe medicinal products,” said Tatiana Vyazmina.

Summarizing the results of the GMP conference, Vladislav Shestakov, Director of the FSI “SID & GP”, emphasized that the joint work of regulators, manufacturers, and suppliers creates the foundation for future breakthroughs in pharmaceuticals. The industry successfully overcomes crises and strives not only for the development of GMP practices but also for strengthening technological leadership, with the common goal of providing patients worldwide with high-quality, safe, and effective medicines.

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