On 29 January 2026, representatives of the European Business Association (EBA) visited the State Expert Center of the Ministry of Health of Ukraine. During the meeting, they presented acknowledgements to the management and specialists of the Center for their significant contribution to the digital transformation of the state registration process for medicinal products – the implementation of eCTD in Ukraine.
The EBA representatives noted the efficiency, well-coordinated teamwork of the State Expert Center and the high quality of the implementation of the international eCTD format, which is already operational, significantly simplifies interaction between applicants and the Center and aligns with modern European approaches.
Deputy Director of the State Expert Center for Health Technology Assessment and Clinical Trials Yevheniia Ishkova thanked the European Business Association for its consistent support of eCTD implementation at all stages and active assistance in its integration in Ukraine: "The launch of eCTD became possible thanks to joint work, mutual trust and constructive dialogue between all stakeholders. It is very important for us that this format has been introduced, that it is supported and developed further. eCTD creates clear and uniform rules of interaction, reduces the administrative burden for applicants, increases the efficiency of expert evaluation and provides a more transparent and faster path for medicinal products to the patient," emphasized Yevheniia Ishkova.
As is known, voluntary submission of registration materials in eCTD format became possible from March 2025. And from August 2025, in accordance with legislation, the process of submitting registration dossiers for new registrations of medicinal products in eCTD became mandatory.
eCTD is an electronic international standard that ensures an integral history of data throughout the entire life cycle of a medicinal product. This is not only a transition from paper to digital solutions, but also an important step of Ukraine towards harmonization with European regulatory requirements.
As of today, 311 registration dossiers have already been submitted for medicinal products applied for state registration (re-registration) and amendments.
