Darnytsia — Driver of Ukraine’s Integration Into the International Pharmaceutical Space
Darnytsia Pharmaceutical Company actively implements international standards and practices in its operations and supports state initiatives for the integration of Ukrainian pharmaceuticals into the global space.
The company’s participation in key industry forums, in particular the pharmaceutical forum “PHARMEXPERT 2025. eCTD and Pricing in Ukraine – a Strategic Path to Integration into the International Regulatory Space,” confirms Darnytsia’s leading position in the processes of digitalization, transparency, and harmonization of regulatory procedures in line with European requirements.
The event, which took place on June 17 in Kyiv, brought together leading experts, representatives of government agencies, international organizations, pharmaceutical manufacturers, and patient communities to discuss key reforms in the field of pharmaceutical regulation.
Among the forum’s speakers were representatives of Darnytsia, who shared their own experience in implementing the international eCTD format for the registration of medicinal products, as well as their vision regarding pricing transparency in the pharmaceutical market.
Kateryna Turlina, Head of the Ukrainian Registration Department at Darnytsia, spoke about the path the company has taken in implementing eCTD. In particular, she shared the challenges the company faced during the test period of eCTD implementation, explained how they were overcome, and described the advantages that can already be felt from the introduction of eCTD.
“Electronic submission of registration dossiers is not only about a digital future and convenience, but also about the environmental responsibility of our business. After all, abandoning paper dossiers allows us to significantly reduce paper consumption. Those who work in the regulatory field know well how labor-intensive the preparation of each submission is: hundreds of pages of paper, numerous document versions, amendments, and so on. For example, a single registration dossier can contain from 10,000 to 50,000 pages. So we cannot remain in the paper past — let’s move into the future together,” urged Kateryna Turlina.
Let us recall that Darnytsia was the first Ukrainian pharmaceutical manufacturer to begin the transition to electronic submission of registration dossiers in the eCTD format back in October 2024.
In the first 6 months of 2025, the company submitted 3 medicinal products for state registration in electronic format (ampoules, tablets, infusions), 1 medicinal product in two dosages for re-registration, and 2 medicinal products for the procedure of making changes.
The issue of transparency and fairness in the pharmaceutical market was continued in the speech of Kostiantyn Vashchenko, Government Relations Director at Darnytsia.
He emphasized the importance of transparent pricing rules and the responsibility of all players operating in the pharmaceutical market — manufacturers, distributors, and pharmacies. After all, the top priority is people’s health.
“We are not against marketing, but we stand for a transparent list of services and fair rules of the game for all market participants. As a leading national manufacturer, we are, to some extent, responsible for the implementation of state policy, which should be in the interests of the patient and meet the best European standards. Moreover, in times of war, the pharmaceutical sector is an element of critical infrastructure, so it requires special protection and proper attention,” said Kostiantyn Vashchenko.
He also emphasized that Darnytsia signed a memorandum to reduce prices for medicinal products, even despite losing part of its profits.
“We consciously decided to lower prices, understanding our social responsibility. This is our contribution to making medicines more accessible for Ukrainians in difficult times. We strive for reforms to be transparent and for the market to be fair and competitive for everyone,” summarized Kostiantyn Vashchenko.
Darnytsia will continue to be a driver of change, open to cooperation, innovation, and new challenges. After all, the future of Ukrainian pharmaceuticals is a future created together with those who are not afraid to think big, act responsibly, and move forward with confidence.
