Webinar on the Implementation of eCTD in Ukraine: Key Changes and Technical Aspects

On April 2, 2025, iRIS Soft successfully conducted a training webinar dedicated to the implementation of the electronic Common Technical Document (eCTD) in Ukraine — a modern format for regulatory dossier submission aligned with ICH international standards.

The event was held in the context of preparations for the mandatory transition to eCTD, which will come into force on August 18, 2025, in accordance with the Law of Ukraine “On Medicinal Products.” The webinar gathered representatives from pharmaceutical companies, regulatory professionals, and technical specialists interested in adopting the new submission format.

Participants received a comprehensive overview of the methodological and technical aspects of eCTD implementation in Ukraine. Key topics included:

• Transition periods in Ukraine and the EU
• Scope of application and exceptions
• Technical requirements for dossier submission
• Module 1 UA eCTD specifications
• Use of qualified electronic signatures
• Lifecycle management and sequence handling
• Responding to comments and managing amendments

A highlight of the session was the live demonstration of the Electronic Dossier Management System eCTD-RIMS developed by iRIS Soft.

Key Features of the eCTD-RIMS System:

• Management of sequences and regulatory dossiers
• Automatic generation of unique sequence identifiers (UUID)
• Baseline submission preparation
• History tracking of submissions within a single dossier
• eCTD structure generation according to Module 1 (UA) and Modules 2–5 (ICH) specifications
• File naming and status control during sequence creation
• Support for qualified electronic signatures
• Validation of the dossier prior to submission
• Logging of State Expert Center comments and submitted responses
• Automatic generation of print-ready lists of sequence documents and tracking tables
• Support for collaborative dossier preparation by multiple departments
• Archive file generation for submission via the Applicant’s Cabinet of the State Expert Center

Speakers:

Daria Ferents, Technical Director
– Degree in Cybernetics, Taras Shevchenko National University of Kyiv
– Over 18 years of experience in business analysis and development of pharmacovigilance projects, including the Automated Pharmacovigilance Information System of the State Expert Center of the Ministry of Health of Ukraine, and document and dossier management systems for pharmaceutical and medical enterprises

Ninel Uskova, Head of Business Analysis Department
– Degree in Control Systems, Kyiv Polytechnic Institute
– Over 15 years of experience in automation of document workflow processes for government agencies and pharmaceutical companies

The event served as a crucial step toward a deeper understanding of regulatory and technical requirements and familiarized participants with digital tools for a successful transition to the eCTD format.