New Release of the Electronic Dossier Management System eCTD-RIMS

iRIS Soft has completed the development of a new release of the Electronic Dossier Management System eCTD-RIMS. The new version incorporates user suggestions for improving system efficiency, as well as experience accumulated during system operation and submission of eCTD documents to the Applicant’s Cabinet of the State Expert Center of the Ministry of Health of Ukraine (SEC).

During its use, the eCTD-RIMS system has demonstrated effectiveness, reliability, and compliance with international standards. The built-in pre-validation tools ensure successful technical validation of eCTD sequences in the SEC Applicant’s Cabinet and their subsequent acceptance for scientific review.

The new release includes a range of technical and functional improvements aimed at enhancing user convenience and compliance with regulatory requirements. Specifically, the following updates have been implemented:

• configuration of sequence envelope attributes in accordance with national requirements;
• improvement of the eCTD archive file format;
• correction of identified errors;
• enhancement of system functionality.

The updated version of eCTD-RIMS complies with the Order of the Ministry of Health of Ukraine No. 691 dated April 23, 2024, which establishes mandatory requirements for the structure and format of Module 1 of the electronic Common Technical Document (eCTD), as well as validation criteria. This ensures the alignment of submissions with regulatory requirements and promotes effective interaction with the SEC. The system also follows best practices for regulatory communication in Ukraine.

Key updates include:

• envelope (Envelope) formation in accordance with established requirements;
• generation of the eCTD archive file according to validation criteria;
• control of mandatory completion of the related sequence number;
• refinement of the Intelligent Assistant to ensure correct file naming, along with an updated algorithm for name validity and length verification;
• addition of a button to close the sequence after submission;
• removal of restrictions on downloading the sequence archive file — it is now accessible regardless of the sequence status;
• introduction of hyperlink creation between sequences for convenient tracking of submission history;
• ability to attach documents signed with a qualified electronic signature (QES) outside the system;
• improved automatic generation of the sequence tracking table;
• correction of identified system errors.

Comprehensive system testing conducted by iRIS Soft specialists enabled confident adaptation of archive file generation in accordance with current validation requirements, significantly simplifying the work of dossier preparation specialists and improving the efficiency of regulatory interaction.

Keywords: electronic Common Technical Document (eCTD), medical matters, registration dossier, software solution, SEC Applicant’s Cabinet, eCTD document validation, Module 1 UA eCTD specification, eCTD-RIMS system release.