Implementation of the Law on Medicinal Products, the Ukrainian Pharmaceutical Agency, and updated approaches to bioequivalence: Outcomes of the EBA–SEC MoH meeting

27/ 03/ 2026

On 24 March, a working meeting was held between the Registration Subcommittee of the Health Care Committee of the European Business Association and Edem Adamanov, Director of the State Enterprise “State Expert Centre of the Ministry of Health of Ukraine” (SEC), together with his team of experts. The discussion focused on regulatory predictability, the practical implementation of new requirements for registration procedures, and the challenges faced by applicants. A separate block addressed alignment with European and international approaches. One of the key topics of the meeting was the demonstration of bioequivalence of medicinal products in the context of the new Law of Ukraine “On Medicinal Products” No. 2469-IX. In view of the need to bring registration materials into compliance with this Law and EU legislation governing the circulation of medicinal products, SEC experts presented regulatory and practical approaches to bioequivalence assessment. They outlined categories of medicinal products for which such studies are required and introduced a draft of the main approaches to revising registration dossiers. A separate part of the discussion was devoted to institutional changes in the pharmaceutical sector, in particular the establishment of the Ukrainian Pharmaceutical Agency. The SEC presented possible approaches to organising the future authority, taking into account the distribution of regulatory, expert, and service functions, and outlined their potential impact on registration procedures, pharmacovigilance, and other key processes. In this context, participants emphasised the importance of maintaining stable regulatory procedures, preserving expert capacity, and developing a predictable model of interaction with applicants. The meeting also covered practical aspects of implementing the Law on Medicinal Products for businesses. This included issues requiring further clarification, early coordination, and alignment of approaches between the regulator and the market to ensure transparency of procedures and proper preparation for upcoming changes. SEC experts noted that all registration procedures initiated in 2026 will be completed, and that the review of materials is ongoing as usual. The Association’s Committee highlighted the need to take into account companies’ positions, as well as the importance of further improving communication with applicants through the timely publication of information notices on the SEC website. Such meetings are essential for fostering an open and professional dialogue between the state and business. For the pharmaceutical sector, timely discussion of upcoming regulatory decisions is particularly important, as the consistency of approaches and predictability of procedures directly affect the stability of medicinal product supply and uninterrupted patient access to treatment. The Health Care Committee of the European Business Association expresses its gratitude to colleagues at the SEC for the constructive dialogue.

One of the key topics of the meeting was the demonstration of bioequivalence of medicinal products in the context of the new Law of Ukraine “On Medicinal Products” No. 2469-IX. In view of the need to bring registration materials into compliance with this Law and EU legislation governing the circulation of medicinal products, SEC experts presented regulatory and practical approaches to bioequivalence assessment. They outlined categories of medicinal products for which such studies are required and introduced a draft of the main approaches to revising registration dossiers.

A separate part of the discussion was devoted to institutional changes in the pharmaceutical sector, in particular the establishment of the Ukrainian Pharmaceutical Agency. The SEC presented possible approaches to organising the future authority, taking into account the distribution of regulatory, expert, and service functions, and outlined their potential impact on registration procedures, pharmacovigilance, and other key processes. In this context, participants emphasised the importance of maintaining stable regulatory procedures, preserving expert capacity, and developing a predictable model of interaction with applicants.

The meeting also covered practical aspects of implementing the Law on Medicinal Products for businesses. This included issues requiring further clarification, early coordination, and alignment of approaches between the regulator and the market to ensure transparency of procedures and proper preparation for upcoming changes. SEC experts noted that all registration procedures initiated in 2026 will be completed, and that the review of materials is ongoing as usual. The Association’s Committee highlighted the need to take into account companies’ positions, as well as the importance of further improving communication with applicants through the timely publication of information notices on the SEC website.

Such meetings are essential for fostering an open and professional dialogue between the state and business. For the pharmaceutical sector, timely discussion of upcoming regulatory decisions is particularly important, as the consistency of approaches and predictability of procedures directly affect the stability of medicinal product supply and uninterrupted patient access to treatment.

The Health Care Committee of the European Business Association expresses its gratitude to colleagues at the SEC for the constructive dialogue.