On 12 May 2026, the forum "PHARMEXPERT 2026: the pharmaceutical market in a new regulatory reality" was held. Organizers: Proxima Research International and the State Expert Center of the Ministry of Health of Ukraine
The event brought together representatives of regulators, business, the expert community, professional associations and the patient community for a dialogue on the future of Ukraine's pharmaceutical sector.
From 2027, a new regulatory model harmonized with European requirements will start operating in the domestic pharmaceutical market. The key basis for the changes will be the new edition of the Law of Ukraine "On Medicinal Products".
Opening the forum, the Director of the State Expert Center of the Ministry of Health of Ukraine, Edem Adamanov, emphasized that such a transformation is an irreversible process driven not only by Ukraine's European integration commitments but also by the need to enhance the resilience of the healthcare system during the war.
"Today we are defining not just market rules. We are defining what the system of access to treatment in the country will be. Regulatory transformation is no longer a matter of choice, but a matter of the state's responsibility to the patient," emphasized Edem Adamanov.
In his report, the director of the State Expert Center emphasized that the digitalization of regulatory procedures, the development of an evidence-based approach, strengthening the patient-centeredness of the healthcare system, and the creation of a modern model of state control in the pharmaceutical sector — the Ukrainian Pharmaceutical Agency — remain relevant today.
"A modern regulator should be not a barrier but an independent arbiter that ensures transparent rules and a balance of interests among the state, business, and the patient," emphasized Edem Adamanov.
The key topics of the forum were new requirements for the state registration of medicinal products, the implementation of eCTD, the accessibility of therapy for patients, as well as the balance between state regulation and market mechanisms.
During the session dedicated to the registration of medicinal products and bioequivalence, the key changes envisaged by the new edition of the Law of Ukraine "On Medicinal Products" were presented. Among the main innovations are registration dossiers in the electronic eCTD format, a verification system and 2D-coding to combat falsification, and enhanced transparency regarding importers, registration holders, and regulator decisions.
Market operators showed interest in the round table: "Registration of medicinal products and bioequivalence", where participants were able to ask important questions about the procedure for reviewing registration dossiers in accordance with the requirements of the new Law in the context of bioequivalence.
In particular, the discussion covered the practical aspects of implementing the transition period for products registered in previous years, possible evaluation criteria and national specifics.
During the workshop "eCTD in Ukraine — practical aspects of implementation", the technical and organizational aspects of the transition to the electronic format of dossier submission were discussed, including for re-registration and variation procedures, as well as the market's readiness to implement new digital tools.
Within the panel discussions, the issues of availability of medicinal products, price declaration and reference pricing, marketing practices, credit notes, the role of hospital pharmacies, the sale of over-the-counter medicinal products outside pharmacies and others were also considered.
One of the central topics of the forum was the role of the state in ensuring a balance between the availability of medicinal products, market mechanisms and requirements for the quality and safety of therapy.
Forum participants also emphasized the importance of building a predictable and evidence-based regulatory system based on open dialogue between the state and the market.
According to Edem Adamanov, the Center is ready to be an open platform for professional communication and interaction among all market participants.
In conclusion, the forum participants emphasised: the further transformation of the pharmaceutical sector requires not only updating the regulatory framework, but also compliance with the rules by all market participants. The goal is to create a modern and effective healthcare system with the patient at its center.
