On 17 July 2026, the State Expert Center of the Ministry of Health of Ukraine held an open dialogue with business, "New Regulatory Requirements and Continuity of Procedures during the Transition Period: A Guide for Applicants".
The meeting was attended by about 250 representatives of pharmaceutical companies, professional associations, and the legal and expert communities. The purpose of the event was to provide applicants with clear guidelines on the practical implementation of the provisions of the new legislation, to explain the specifics of how the regulatory system operates during the transition period, and to discuss how to ensure the continuity of procedures already initiated.
The focus was on state registration of medicinal products, confirmation of bioequivalence, clinical trials, tariff policy, legal aspects of the transition period, compliance, and transparency of regulatory decisions.
Opening the meeting, the Director of the State Expert Center, Edem Adamanov, emphasized that the regulatory and organizational changes envisaged by the new Law of Ukraine "On Medicinal Products", which enters into force on 1 January 2027, must take place continuously and must not lead to the suspension of regulatory procedures or the creation of additional burden for applicants.
"The law has no retroactive effect, therefore all procedures that have been initiated or will be initiated in 2026 in accordance with the current requirements must be completed. The Center has the necessary institutional capacity, expert resources and all prerequisites for fulfilling its commitments. It is fundamentally important for us to ensure legal certainty for applicants, to prevent the interruption of regulatory processes and to retain the expert team that will become the foundation for the future agency," emphasized Edem Adamanov.
The first block of the event was devoted to issues that companies should take into account when planning their work before the entry into force of the new Law of Ukraine "On Medicinal Products".
One of the important elements of the future system will be a new funding model. The issue of tariff policy and planning during the transition period was highlighted by Deputy Director of the Center Daria Pakhomova. She noted that the amounts of fees and tariffs in the new system should be established by the Cabinet of Ministers of Ukraine. Until the relevant decisions are adopted, it is difficult to fully assess future costs. Under these conditions, timely submission of documents to the Center has not only procedural but also economic significance.
"Working within the current system gives applicants the opportunity to act in accordance with clear and stable requirements defined by interaction procedures and predictable financial conditions. This allows minimizing the risks of the transition period, ensuring continuity of regulatory processes and planning operational activities and budget expenditures more effectively," emphasized Daria Pakhomova.
Funding is only one of the issues that will change. It is equally important to understand the new rules of state registration of medicinal products, which were presented by the Director of the Department of Expert Evaluation of Registration Materials Iryna Reshetniak.
They discussed new requirements for applicants and their representatives, electronic submission of materials in eCTD format, changes to the timelines of procedures, the introduction of 2D-coding on packaging, and the need to bring registration materials into line with scientific and technical progress.
Applicants were advised to check access to the Electronic Cabinet in advance, prepare a dossier in eCTD format, and determine which changes would need to be made to the registration materials.
Considerable attention of the dialogue participants was drawn to the topic of reviewing registration dossiers with regard to confirmation of bioequivalence. The Director of the Department for Assessment of Bioavailability and Equivalence, Nadiia Zhukova, spoke about possible criteria and the main approaches to assessing bioequivalence evidence, nuances that should be taken into account already now, and the algorithm of applicants' actions during dossier assessment. In particular, the discussion concerned medicinal products registered under the requirements of previous years, products that have been on the market for a long time, as well as medicinal products registered on the basis of confirmation of pharmaceutical equivalence.
Another area for which new requirements are envisaged is the conduct of clinical trials. Deputy Director of the Center for Health Technology Assessment and Clinical Research Yevheniia Ishkova presented to the participants a comprehensive overview of the current regulatory changes in the field of clinical trials. The presentation covered the introduction of an administrative service and digital services, in particular the applicant's electronic cabinet, key changes to MoH order No. 690 as amended by order No. 302, as well as new regulatory approaches that will enter into force as early as 2027. At the end of the presentation, Yevheniia Ishkova urged market representatives not to postpone preparation for the upcoming changes, but to work out practical issues in advance together with the Center in order to ensure a smooth and effective transition to the new regulatory requirements.
Managing Partner of LA Law Firm Dmytro Aleshko focused on the legal risks of the transition period and issues requiring additional regulatory settlement in connection with the introduction of new legislation on medicinal products. In particular, he outlined gaps regarding the completion of initiated regulatory procedures, bringing registration certificates and the status of marketing authorisation holders into compliance with new requirements, as well as the specifics of representation of foreign applicants. Separately, the issues of import, GMP/GDP requirements, labelling and possible risks to the continuity of circulation of medicinal products in the absence of clear transitional mechanisms were considered.
The first block of the dialogue was concluded by a presentation on compliance, transparency of procedures and interaction with applicants. Deputy Director of the Center for Compliance and Risk Management Denys Cherednyk spoke about preventing conflicts of interest and protecting expert decisions from external influence. The task of the compliance system is to ensure that decisions are based on scientific data, adopted impartially and are understandable to applicants.
The second part of the meeting was devoted to an open question-and-answer session with the participation of the management of the State Expert Center, the heads of relevant divisions and invited experts. Participants of the event were able to raise practical problems and receive clarifications on the completion of initiated procedures, the preparation of registration dossiers for new requirements, confirmation of bioequivalence, requirements for Ukrainian manufacturers, application of transitional provisions, changes in the field of clinical trials and pharmacovigilance, and the operation of electronic systems.
The event became a continuation of the systemic dialogue of the State Expert Center with representatives of the pharmaceutical business at the stage of transition to new legislation and the formation of a new regulatory system with the start of operation of the Ukrainian Pharmaceutical Agency.
The State Expert Center will continue to remain an open platform for professional interaction between the regulator, business, the expert community and the public. Such a format will contribute to the timely preparation of market participants for changes, reducing the level of uncertainty and ensuring a predictable and uninterrupted transition to the new system of regulation of medicinal products.
