EBA welcomes the launch of eCTD for new medicinal product registrations

22/ 08/ 2025

According to information published by the Ministry of Health of Ukraine, at the start of mandatory submissions in the eCTD format, 72 dossiers have already been filed (18 for initial registration, 5 for re-registration, and 49 for variations), alongside 343 electronic applications through the Single Window. This demonstrates both the effective implementation of the decision and the market’s readiness to work within a modern technical standard. The European Business Association warmly congratulates the team of the Ministry of Health and the State Expert Centre (SEC) of the MoH of Ukraine — in particular, Maria Karchevych, Deputy Minister of Health for Digital Development, Digital Transformations and Digitalisation; Mykhailo Babenko, Director of the SEC; Yevheniia Ishkova, Deputy Director of the SEC; Artem Klieb, Head of the IT Department of the SEC; and Olha Kolesova, Expert of the Department for the Examination of Registration Materials — on the well-coordinated launch of mandatory eCTD submissions for new registrations as of 18 August 2025. This decision strengthens procedural transparency, improves data quality, and brings Ukraine closer to European regulatory practices. Electronic interaction with the regulator is becoming a common business tool, enhancing both the predictability and speed of procedures. The EBA also extends sincere appreciation to applicants who actively participated in the pilot project — their involvement and constructive feedback were key to the successful adoption of the new standards. The European Business Association consistently supports the digitalisation of regulatory processes and will continue to cooperate with the MoH, the SEC, and member companies on further systemic reforms and harmonisation with European standards and best practices. This approach will foster a more transparent and competitive market, ultimately ensuring that patients gain access to higher-quality and more advanced treatment methods.

The European Business Association warmly congratulates the team of the Ministry of Health and the State Expert Centre (SEC) of the MoH of Ukraine — in particular, Maria Karchevych, Deputy Minister of Health for Digital Development, Digital Transformations and Digitalisation; Mykhailo Babenko, Director of the SEC; Yevheniia Ishkova, Deputy Director of the SEC; Artem Klieb, Head of the IT Department of the SEC; and Olha Kolesova, Expert of the Department for the Examination of Registration Materials — on the well-coordinated launch of mandatory eCTD submissions for new registrations as of 18 August 2025. This decision strengthens procedural transparency, improves data quality, and brings Ukraine closer to European regulatory practices.

Electronic interaction with the regulator is becoming a common business tool, enhancing both the predictability and speed of procedures. The EBA also extends sincere appreciation to applicants who actively participated in the pilot project — their involvement and constructive feedback were key to the successful adoption of the new standards.

The European Business Association consistently supports the digitalisation of regulatory processes and will continue to cooperate with the MoH, the SEC, and member companies on further systemic reforms and harmonisation with European standards and best practices. This approach will foster a more transparent and competitive market, ultimately ensuring that patients gain access to higher-quality and more advanced treatment methods.