THE FORUM HAS TAKEN PLACE!
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 regulatory authorities, business, the expert community, professional associations and the patient community for a dialogue on the future of Ukraine's pharmaceutical sector.
At the center of the discussion is the large-scale transformation of the market, which starts in 2027. The Ukrainian pharmaceutical system will begin to operate under a new regulatory model harmonized with European requirements. The basis of the changes will be the new version of the Law of Ukraine "On Medicinal Products", which provides for new requirements for state registration of medicinal products, proof of bioequivalence, pharmacovigilance, the creation of a modern state control body in the pharmaceutical sector and other innovations.
Opening the forum, the Director of the State Expert Center of the Ministry of Health of Ukraine, Edem Adamanov, emphasized that the transformation of Ukraine's pharmaceutical sector is irreversible and is driven not only by Ukraine's European integration obligations, but also by the need to increase the resilience of the healthcare system in wartime conditions.
"Today we are defining more than 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," noted Edem Adamanov.
In his report, the Director of the State Expert Center outlined the key priorities for the development of the industry:
- digitalization of regulatory procedures;
- development of an evidence-based approach;
- strengthening the patient-centredness of the healthcare system;
- creation of a modern model of state control in the pharmaceutical industry.
"A modern regulator must be not a barrier, but an independent arbiter that ensures transparent rules and a balance of interests of the state, business and the patient," emphasised the Director of the State Expert Center.
The key topics of the forum were new approaches to state registration of medicinal products, the introduction of eCTD, 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 Deputy Director for Registration, Pharmacovigilance and Audit Olena Semenchenko presented the key changes envisaged by the new edition of the Law of Ukraine "On Medicinal Products". Among the main innovations for applicants are the transition to the electronic format of registration dossiers eCTD, the introduction of a verification system and 2D-coding to combat falsified products, and the strengthening of transparency regarding importers, registration holders and regulatory decisions.
The panel discussion "Access and Availability of Medicinal Products for Patients" was joined by the Deputy Director of the Center for Health Technology Assessment and Clinical Research Yevheniia Ishkova and the Director of the HTA Department Oresta Piniazhko. The focus was on the issues of reference pricing and price declaration for medicines. Participants emphasised that effective state regulation is impossible without quality communication between all stakeholders.
Particular attention was paid to the submission of applications for the declaration of maximum wholesale-release prices through the Electronic Cabinet and its updated functionality. Digital solutions automatically synchronise data with the State Register of Medicinal Products, which allows technical errors to be minimised and the time for their correction to be significantly reduced.
As Yevheniia Ishkova noted, the Center remains ready to cooperate with market participants to improve patients' access to medicinal products.
The topic of digitalisation of regulatory procedures in Ukraine drew considerable attention from the event participants. Director for Digital Transformation of the State Expert Center Ihor Lysenko reported that in 2025 the Center introduced the international format for electronic submission of registration materials eCTD, improved the applicant's electronic Cabinet, modernised the IT infrastructure, launched the e-Queue, the web portal of the National Price Catalogue and other digital services.
Among the key areas of further digitalisation are the development of a new State Register of Medicinal Products, the introduction of electronic submission for all registration procedures, the building of a modern data management system in line with European approaches, and the creation of the State Expert Center's digital hub.
Market operators showed particular interest in the roundtable "Registration of Medicinal Products and Bioequivalence", during which participants discussed 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. The questions of the participants were answered by the Director of the State Expert Center Edem Adamanov and the Head of the Department of Bioavailability and Equivalence Assessment Nadiia Zhukova.
Within the framework of the forum, a thematic workshop "eCTD in Ukraine – Practical Aspects of Implementation" was also held. The focus was on the technical and organizational aspects of the transition to the electronic format of dossier submission, in particular for re-registration and variation procedures, and the market's readiness for the introduction of new digital tools.
During 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 pharmacy establishments and other topical issues of the industry were also considered.
The forum participants emphasized the importance of building a predictable and evidence-based regulatory system founded on open dialogue between the state and the market.
Summing up the forum, the participants emphasized: the further transformation of the pharmaceutical sector requires not only updating the regulatory framework, but also responsible 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.
Forum materials
Forum landing page
FORUM PROGRAM.docx
