The 13th edition of the partnership “Medicines of Russia – towards an interdisciplinary dialogue. From the quality of pharmacovigilance to the quality of life” was successfully concluded in Kaliningrad on September 26, 2025. The event attracted over 180 in-person and online participants and traditionally brought together professionals from the pharmaceutical market to discuss key issues related to drug supply and regulation. This year, the event expanded significantly by dedicating a separate section to pharmacovigilance.

The partners were co-organized by:

• The Association of Russian Pharmaceutical Manufacturers (ARFP);
• The Ministry of Health of the Kaliningrad Region;
• The Association of Pharmacovigilance and Safety Monitoring of Medical Devices;;
• Pharmcomplyance Agency for Pharmacovigilance LLC.

With the support of:

• The Public Council under Roszdravnadzor;
• The Territorial Body of the Federal Service for Supervision of Healthcare in the Kaliningrad Region.

The first part of the conference focused on federal and regional procurement procedures for medicines under state guarantees, as well as current pricing issues.

The Association of Russian Pharmaceutical Manufacturers proposed revising the approach to excluding drugs from the List of Vital and Essential Drugs and introducing a special scoring system for assessment. “This will allow for more rational spending of budgetary funds while maintaining the stability of drug supply,” noted Viktor Dmitriev, General Director of the ARFP.

Dmitry Galkin, Director of the Department for the Development of the Pharmaceutical and Medical Industry of the Russian Ministry of Industry and Trade, during his speech, discussed the released draft of methodological recommendations that detail what is considered chemical synthesis. As noted, the document was developed as part of the preparation for launching the “second is redundant” mechanism and is intended for market participants for discussion.

The second part of the event was entirely dedicated to pharmacovigilance issues—regulatory affairs, rational pharmacotherapy, drug safety and efficacy, as well as challenges in personnel training and enhancing the importance and prestige of the profession. The session brought together representatives of regulatory authorities and leading industry experts from Russia, Belarus, Kazakhstan, and Bulgaria.

Significant attention was given to pharmacovigilance inspections. Representatives of regulatory authorities—Kirill Gorelov (Acting Head of the Department for Organizing State Quality Control of Medical Products of Roszdravnadzor), Irina Efremova (Head of the Republican Clinical and Pharmacological Laboratory of the “Center for Expertise and Testing in Healthcare” of the Republic of Belarus), and Malik Abdrakhmanov (Head of the Pharmacovigilance, Safety Monitoring, Efficacy, and Quality of Medical Devices Department of the RSE “National Center for Expertise of Medicines and Medical Devices” of the Ministry of Health of the Republic of Kazakhstan)—shared perspectives on the development of pharmacovigilance inspections, experience in conducting inspections, and trends in violations. The speakers emphasized the significance of inspections as an integral element in the development of pharmacovigilance systems, as well as the importance of international exchange of information and best practices in the field of inspection activities.

As noted by the organizers and participants of the conference, including a separate section on pharmacovigilance in the program of the current XIII Partnership was an important step in consolidating the experience of regulators and specialists from different countries. The event once again confirmed its status as a leading platform for productive dialogue between regulators, businesses, and the professional community.

About the event on the portals of co-organizers, information partners, and in the media: the Public Council under Roszdravnadzor, the ARFP, the Pharmacovigilance Association, the Pharmaceutical Bulletin, GxP News, Moscow Pharmacies, RBC