Darnytsia Becomes the First in Ukraine to Register a Medicinal Product in eCTD Format: A New Era of Digital Pharmaceuticals
On July 8, 2025, Darnytsia Pharmaceutical Company officially completed the state registration of a medicinal product in the eCTD format—for the first time in Ukraine’s history. This event marks the beginning of a new era of digital transformation in the country’s pharmaceutical sector.
Just a few years ago, the eCTD (electronic Common Technical Document) format seemed like something from the future for Ukraine. It was discussed at conferences, the experience of the EU and FDA was analyzed, but implementation seemed distant. Today, it has become a reality.
The eCTD format is not just a digital file. It is a unified, transparent approach to submitting registration materials, combining over a thousand documents into a logical navigational architecture—an electronic dossier. This is a new language of communication with the regulator, meeting international standards and ensuring transparency and traceability at every stage of the registration procedure.
“We are standing on the threshold of a new era for the entire Ukrainian pharmaceutical industry. Today is not just our victory—it is a breakthrough for the whole sector, for the country, and for the future of patients. We are the first to open the door to a world where digital technologies become the foundation of transparency, speed, and trust. Behind this achievement are months of hard work, team unity and effort, cooperation with the State Expert Center, and unwavering belief that our pharmaceutical sector meets the world’s best standards.
Digital transformation did not catch us off guard—Darnytsia purposefully and systematically prepared for this stage. Our readiness is evidence of our deep responsibility for the development of the digital regulatory ecosystem. This step opens new opportunities for the entire pharmaceutical industry of Ukraine. We are proud that it was Darnytsia who made this step. The future is already here, and we are creating it together,” emphasized Kateryna Turlina, Head of the Ukrainian Registration Department at Darnytsia Pharmaceutical Company.