EBA joined a working meeting with representatives of the State Expert Centre of the Ministry of Health of Ukraine

18/ 12/ 2025

On 16 December, Iryna Mahdik, Executive Director of the Clinical Trials Subcommittee of the European Business Association, took part in a working meeting with representatives of the State Expert Centre of the Ministry of Health of Ukraine. The meeting focused on the draft Order of the Ministry of Health of Ukraine “Certain Issues Related to the Conduct of Clinical Trials (Studies) of Medicinal Products”, to which the EBA had submitted its proposals during three rounds of public consultations. We would like to remind that the draft Order provides for a comprehensive update of the regulatory framework in the field of clinical trials, in particular: the Procedure for Conducting Clinical Trials (Studies) of Medicinal Products, including annexes; the Model Regulation on Ethics Committees at healthcare institutions where clinical trials are conducted; the Requirements for the form and content of informed consent for participation in clinical trials (studies). Representatives of the EBA note that the new regulatory framework is an important step towards regulating the conduct of clinical trials of medicinal products in line with the Law of Ukraine “On Medicinal Products” No. 2469-IX dated 28 July 2022, which will enter into force on 1 January 2027. The EBA expresses its gratitude to Yevheniia Ishkova, Deputy Director for Clinical Trials and Pharmacovigilance at the State Expert Centre, for organising the meeting, as well as to Taisiia Herasymchuk, Director of the Department for the Expert Review of Preclinical and Clinical Trial Materials at the State Expert Centre, and to all attending representatives of the State Expert Centre for their openness to dialogue and willingness to cooperate in improving the regulatory environment for clinical trials. The parties agreed to continue the dialogue and hold further meetings to discuss the EBA key proposals in more detail, particularly those of fundamental importance for the practical implementation of the new regulatory approach and for ensuring the stable operation of the sector. Constructive and ongoing cooperation between the business community and regulatory authorities is critically important, as the adopted regulatory act will have a long-term systemic impact on the entire clinical research sector in Ukraine and will shape the foundation of Ukraine’s competitiveness in the global clinical trials market. The ЕВА Clinical Trials Subcommittee remains open to professional dialogue and ready to provide expert support aimed at improving the regulatory environment for the clinical research sector and fostering the development of Ukraine’s overall scientific and research potential.

The meeting focused on the draft Order of the Ministry of Health of Ukraine “Certain Issues Related to the Conduct of Clinical Trials (Studies) of Medicinal Products”, to which the EBA had submitted its proposals during three rounds of public consultations.

We would like to remind that the draft Order provides for a comprehensive update of the regulatory framework in the field of clinical trials, in particular:

the Procedure for Conducting Clinical Trials (Studies) of Medicinal Products, including annexes;
the Model Regulation on Ethics Committees at healthcare institutions where clinical trials are conducted;
the Requirements for the form and content of informed consent for participation in clinical trials (studies).

Representatives of the EBA note that the new regulatory framework is an important step towards regulating the conduct of clinical trials of medicinal products in line with the Law of Ukraine “On Medicinal Products” No. 2469-IX dated 28 July 2022, which will enter into force on 1 January 2027.

The EBA expresses its gratitude to Yevheniia Ishkova, Deputy Director for Clinical Trials and Pharmacovigilance at the State Expert Centre, for organising the meeting, as well as to Taisiia Herasymchuk, Director of the Department for the Expert Review of Preclinical and Clinical Trial Materials at the State Expert Centre, and to all attending representatives of the State Expert Centre for their openness to dialogue and willingness to cooperate in improving the regulatory environment for clinical trials.

The parties agreed to continue the dialogue and hold further meetings to discuss the EBA key proposals in more detail, particularly those of fundamental importance for the practical implementation of the new regulatory approach and for ensuring the stable operation of the sector.

Constructive and ongoing cooperation between the business community and regulatory authorities is critically important, as the adopted regulatory act will have a long-term systemic impact on the entire clinical research sector in Ukraine and will shape the foundation of Ukraine’s competitiveness in the global clinical trials market.

The ЕВА Clinical Trials Subcommittee remains open to professional dialogue and ready to provide expert support aimed at improving the regulatory environment for the clinical research sector and fostering the development of Ukraine’s overall scientific and research potential.