As of August 18, 2025, Ukraine has introduced the mandatory submission of drug registration dossiers in the international eCTD (electronic Common Technical Document) format. In alignment with this regulatory shift, Farmak has fully transitioned to compiling and submitting its registration dossiers in eCTD format starting that same month.
The eCTD is a globally recognized electronic standard used by pharmaceutical companies to submit documentation to regulatory authorities. In Ukraine, such submissions are reviewed by the State Expert Center of the Ministry of Health.
A registration dossier for a medicinal product contains critical information, including the drug’s composition, manufacturing process, results of clinical trials, quality control data for active substances and finished products, patient information leaflets, and other materials that prove the safety, efficacy, and quality of the medicinal product.
Previously, the registration process in Ukraine relied on paper-based submissions, often amounting to hundreds of thousands of pages, packed into dozens of boxes, requiring complex logistics and storage. The adoption of the eCTD format enables faster updates, streamlined tracking of documentation changes, transparent communication with regulators, and more efficient cross-functional collaboration within the company.
The first medicinal product submitted by Farmak in eCTD format was an antidepressant indicated for the treatment of social anxiety disorder and post-traumatic stress disorder (PTSD). From now on, all new registration dossiers by Farmak will be submitted exclusively in electronic format.
The implementation of eCTD in Ukraine reflects a global regulatory trend. This format has been mandatory for years in the United States, the European Union, Canada, Japan, and Switzerland, and is increasingly adopted across the Middle East and Asia.
