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The SCE and the EBA Clinical Trials Subcommittee agree on further cooperation

14/ 05/ 2026
  On 8 May, the Clinical Trials Subcommittee of the European Business Association held a meeting with representatives of the State Expert Centre of the Ministry of Health of Ukraine. The SEC was represented by Yevheniia Ishkova, Deputy Director for Health Technology Assessment and Clinical Trials; Taisa Herasymchuk, Director of the Department for Expert Review of Preclinical and Clinical Trial Materials; and Liliia Komar, Head of the Division for Quality Assessment of Materials for Clinical Trials. The EBA Clinical Trials Subcommittee was represented by Executive Director Iryna Mahdik. During the meeting, participants discussed key issues related to improving the regulatory environment for clinical trials in Ukraine. In particular, they reviewed the preparation of a Memorandum of Cooperation between the SEC and the EBA, including a dedicated annex on clinical trials. The parties agreed to continue jointly refining the structure and content of the document. Special attention was given to the draft Order of the Ministry of Health of Ukraine “On certain issues regarding the import into the customs territory of Ukraine, accounting, storage, use, destruction, disposal or export from the customs territory of investigational medicinal products” and the accompanying draft requirements. Participants emphasised that these documents require substantial refinement to ensure comprehensive regulation of the entire lifecycle of medicinal products, related materials and equipment (including those containing controlled substances), as well as to reflect the non-commercial nature of such operations and other specific features of clinical trial regulation. Another important topic was the implementation of a single ethics committee opinion mechanism in line with EU approaches (EU CTR / CTIS). A dedicated roundtable discussion is planned for June to examine this issue in greater detail. The meeting also addressed the functioning of the electronic applicant portal and the submission of clinical trial applications and documents to the Ministry of Health’s “One-Stop Shop” via this system. Participants agreed to hold an online discussion during the week of 18–22 May with company representatives to resolve practical issues related to the new electronic submission process. In parallel, work is ongoing to reinstate the prepayment mechanism and enable the upload of invoice copies in the applicant portal immediately after issuance and signing. In addition, the parties agreed to organise a joint event in August–September dedicated to improving the quality of clinical trial application submissions, including the analysis of common errors and the provision of practical recommendations. Another joint event is planned for October–November to discuss practical aspects of implementing MoH Order No. 184. The SEC and representatives of the EBA Clinical Trials Subcommittee reaffirmed their commitment to continued structured cooperation aimed at enhancing the efficiency of regulatory procedures in clinical trials and aligning Ukrainian practices with European standards.

On 8 May, the Clinical Trials Subcommittee of the European Business Association held a meeting with representatives of the State Expert Centre of the Ministry of Health of Ukraine.

The SEC was represented by Yevheniia Ishkova, Deputy Director for Health Technology Assessment and Clinical Trials; Taisa Herasymchuk, Director of the Department for Expert Review of Preclinical and Clinical Trial Materials; and Liliia Komar, Head of the Division for Quality Assessment of Materials for Clinical Trials. The EBA Clinical Trials Subcommittee was represented by Executive Director Iryna Mahdik.

During the meeting, participants discussed key issues related to improving the regulatory environment for clinical trials in Ukraine. In particular, they reviewed the preparation of a Memorandum of Cooperation between the SEC and the EBA, including a dedicated annex on clinical trials. The parties agreed to continue jointly refining the structure and content of the document.

Special attention was given to the draft Order of the Ministry of Health of Ukraine “On certain issues regarding the import into the customs territory of Ukraine, accounting, storage, use, destruction, disposal or export from the customs territory of investigational medicinal products” and the accompanying draft requirements. Participants emphasised that these documents require substantial refinement to ensure comprehensive regulation of the entire lifecycle of medicinal products, related materials and equipment (including those containing controlled substances), as well as to reflect the non-commercial nature of such operations and other specific features of clinical trial regulation.

Another important topic was the implementation of a single ethics committee opinion mechanism in line with EU approaches (EU CTR / CTIS). A dedicated roundtable discussion is planned for June to examine this issue in greater detail.

The meeting also addressed the functioning of the electronic applicant portal and the submission of clinical trial applications and documents to the Ministry of Health’s “One-Stop Shop” via this system. Participants agreed to hold an online discussion during the week of 18–22 May with company representatives to resolve practical issues related to the new electronic submission process. In parallel, work is ongoing to reinstate the prepayment mechanism and enable the upload of invoice copies in the applicant portal immediately after issuance and signing.

In addition, the parties agreed to organise a joint event in August–September dedicated to improving the quality of clinical trial application submissions, including the analysis of common errors and the provision of practical recommendations. Another joint event is planned for October–November to discuss practical aspects of implementing MoH Order No. 184.

The SEC and representatives of the EBA Clinical Trials Subcommittee reaffirmed their commitment to continued structured cooperation aimed at enhancing the efficiency of regulatory procedures in clinical trials and aligning Ukrainian practices with European standards.

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