New approaches to the registration of medicinal products in line with EU standards are being developed

On 14 January 2026, a working meeting was held at the Ministry of Health of Ukraine with the participation of Deputy Minister of Health for European Integration Maryna Slobodnichenko.

The discussion was also attended by representatives of the pharmaceutical industry, the State Enterprise “State Expert Center of the Ministry of Health of Ukraine”, the State Service of Ukraine on Medicines and Drugs Control, as well as representatives of the Ministry of Health of Lithuania, including Kristina Povilaitytė, Adviser of the Pharmaceutical Policy Unit.

During the meeting, participants discussed the alignment of medicinal product registration dossiers with the new Law of Ukraine “On Medicinal Products” and relevant European Union legislation.

In this context, particular attention was paid to bioequivalence requirements — confirmation that generic medicines are as effective and safe as originator products. This means that manufacturers of generic medicines must provide appropriate evidence of the quality and therapeutic equivalence of their products. Such an approach is standard practice in EU Member States and is directly aimed at protecting patients and increasing trust in the quality of medicines.

Participants also emphasised the importance of expert support from international partners in the process of harmonising regulatory procedures. Within the framework of the Twinning project, the Ministry of Health of Lithuania currently provides methodological support to the Ukrainian side and shares European experience in implementing regulatory reforms.

It was further underlined that the introduction of new requirements should be transparent, predictable and take into account the real capacities of the market. Therefore, the development of clear and comprehensible rules and procedures for both the regulator and manufacturers is a key element of the process.

Following the meeting, the parties agreed on further steps. In particular, it is important to develop a procedure for bringing registration materials into compliance with EU standards. This document should define unified approaches, sequence of actions, requirements and timelines, which will make the harmonisation process systematic, transparent and consistent with European regulatory practice.

In parallel, representatives of the pharmaceutical industry will, within one month, analyse their product portfolios and submit information to the Ministry regarding medicinal products that will require updating of documentation, as well as those that are not planned to be brought into compliance with the new requirements.

The developed criteria will be submitted for further discussion with market stakeholders.

This work is an important component of Ukraine’s European integration path and a consistent step towards improving the quality, safety and availability of medicines for patients. These actions by the Ministry are also aimed at preserving national pharmaceutical manufacturing. Under general EU rules, generic medicines that have not demonstrated bioequivalence are not allowed to be placed on the market. Aligning registration dossiers with EU standards is therefore an important step for manufacturers not only to maintain their product portfolios in Ukraine, but also to access European markets.

It should be recalled that the EU and Ukraine are strengthening their strategic partnership in the field of medicinal products.