Business discusses practical implementation of the updated Сlinical Trials Procedure with the SEC of the MoH of Ukraine

23/ 06/ 2026

On 18 June, members of the European Business Association’s Clinical Trials Subcommittee held an online meeting with representatives of the State Expert Centre (SEC) of the Ministry of Health of Ukraine. During the meeting, the parties discussed practical aspects of implementing the amendments to the Procedure for Conducting Clinical Trials of Medicinal Products, introduced by Order No. 302 of the Ministry of Health of Ukraine dated 10 March 2026, which amended Order No. 690. Participants reviewed a broad range of issues, including the general implementation of Order No. 302, provisions removed from the previous version of the Procedure, timelines for expert evaluation, and the application of new document templates. Particular attention was paid to the updated procedure for the submission and review of clinical trial materials. Under the new rules, applications together with the full package of supporting documents must be submitted directly to the Ministry of Health, which conducts an initial completeness check before forwarding the materials to the State Expert Centre for specialised assessment. In this context, participants discussed practical aspects of assessing the completeness of submitted materials, the stages of the review process, timelines for expert evaluation, and requirements regarding the submission of documents in both paper and electronic formats. The parties also highlighted the need for further methodological guidance to ensure a consistent approach to the application of the updated requirements. A significant part of the discussion focused on requirements for clinical trial teams, including the qualifications and roles of individual specialists, documentation requirements concerning sub-investigators, and the possibility of involving professionals without medical or pharmaceutical education in organisational and administrative functions within clinical trials. Participants also discussed the labelling of investigational medicinal products, auxiliary medicinal products, and related materials, including requirements for additional labelling, provisions applicable to small packaging, and the possibility of applying alternative approaches harmonised with European legislation. In addition, the parties addressed issues related to informed consent and the use of electronic signatures, requirements for personal data transfers, language aspects of clinical trial documentation, and practical approaches to the use of electronic trust services in clinical research. The discussion also covered a number of practical matters, including the further development of the applicant’s electronic portal, technical limitations regarding document uploads, procedures for submitting materials related to substantial amendments, practical aspects of confirming batch compliance for investigational medicinal products, and the submission of letters of guarantee. The European Business Association expresses its gratitude to the representatives of the State Expert Centre of the Ministry of Health of Ukraine, in particular Taisiia Herasymchuk, Director of the Department for the Evaluation of Pre-Clinical and Clinical Trial Materials, as well as the Centre’s experts, for the open and constructive dialogue, valuable clarifications, and willingness to continue cooperation. The issues raised during the meeting require further consideration and continued professional discussion. The Association hopes that the established practice of regular meetings between representatives of the professional community and regulatory authorities will continue. We are convinced that ongoing bilateral dialogue contributes to a common understanding of regulatory requirements, enhances the predictability of processes, and creates favourable conditions for the development of clinical research in Ukraine for the benefit of both the industry and patients.

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Participants reviewed a broad range of issues, including the general implementation of Order No. 302, provisions removed from the previous version of the Procedure, timelines for expert evaluation, and the application of new document templates.

Particular attention was paid to the updated procedure for the submission and review of clinical trial materials. Under the new rules, applications together with the full package of supporting documents must be submitted directly to the Ministry of Health, which conducts an initial completeness check before forwarding the materials to the State Expert Centre for specialised assessment.

In this context, participants discussed practical aspects of assessing the completeness of submitted materials, the stages of the review process, timelines for expert evaluation, and requirements regarding the submission of documents in both paper and electronic formats. The parties also highlighted the need for further methodological guidance to ensure a consistent approach to the application of the updated requirements.

A significant part of the discussion focused on requirements for clinical trial teams, including the qualifications and roles of individual specialists, documentation requirements concerning sub-investigators, and the possibility of involving professionals without medical or pharmaceutical education in organisational and administrative functions within clinical trials.

Participants also discussed the labelling of investigational medicinal products, auxiliary medicinal products, and related materials, including requirements for additional labelling, provisions applicable to small packaging, and the possibility of applying alternative approaches harmonised with European legislation.

In addition, the parties addressed issues related to informed consent and the use of electronic signatures, requirements for personal data transfers, language aspects of clinical trial documentation, and practical approaches to the use of electronic trust services in clinical research.

The discussion also covered a number of practical matters, including the further development of the applicant’s electronic portal, technical limitations regarding document uploads, procedures for submitting materials related to substantial amendments, practical aspects of confirming batch compliance for investigational medicinal products, and the submission of letters of guarantee.

The European Business Association expresses its gratitude to the representatives of the State Expert Centre of the Ministry of Health of Ukraine, in particular Taisiia Herasymchuk, Director of the Department for the Evaluation of Pre-Clinical and Clinical Trial Materials, as well as the Centre’s experts, for the open and constructive dialogue, valuable clarifications, and willingness to continue cooperation.

The issues raised during the meeting require further consideration and continued professional discussion. The Association hopes that the established practice of regular meetings between representatives of the professional community and regulatory authorities will continue. We are convinced that ongoing bilateral dialogue contributes to a common understanding of regulatory requirements, enhances the predictability of processes, and creates favourable conditions for the development of clinical research in Ukraine for the benefit of both the industry and patients.