Darnytsia Was the First in Ukraine to Submit a Dossier for State Registration of Medicinal Products in the eCTD format
On the way to European integration, Darnytsia Pharmaceutical Company was the first in Ukraine to submit a dossier for state registration of medicinal products in the eCTD format.
Having implemented this solution, the company goes through a test period for its approbation in practice. Officially, submission of all registration documents in the eCTD format will become mandatory from August 2025 in accordance with the Law of Ukraine "On Medicinal Products" dated 28.07.2022 No. 2469-IX.
As a reminder, the Electronic Common Technical Document (eCTD) is a standard used in many countries for the transfer of technical and regulatory documentation for the registration of medicinal products. Its purpose is to unify the format of information exchange between representatives of the pharmaceutical market and regulatory authorities.
Electronic submission of registration dossiers allows companies to communicate with regulators faster and more efficiently, and also ensures greater transparency of the process.
This innovation not only simplifies the work of pharmaceutical manufacturers, but also increases the level of trust in their products by the state and the end consumer.
In particular, the consumer, the care of whom is the focus of attention of responsible pharmaceutical manufacturers, receives effective and safe medicines and confidence in their quality, which meets international standards and is confirmed by a state control authority.
"We thank the team of the State Expert Center of the Ministry of Health for their support in implementing this decision. We are confident that it is the cooperation between business and the state that will contribute to the further implementation of the eCTD format and the provision of high quality and safe medicines to Ukrainian patients, and our experience and efforts will pave the way for other companies, creating new opportunities for improving regulatory processes," said Kateryna Turlina, head of the Department of Ukrainian Registration of Darnytsia Pharmaceutical Company.