iRIS Soft Participates in the “PHARMEXPERT 2025” Forum
The iRIS Soft team actively participated in the “PHARMEXPERT 2025: eCTD and Pricing in Ukraine — A Strategic Path to Integration into the International Regulatory Environment” forum, held on June 17, 2025, in Kyiv. During the event, the company presented its own innovative solution — the Electronic Dossier Management System eCTD-RIMS. iRIS Soft representatives joined the professional dialogue on the digital transformation of the regulatory landscape, particularly the implementation of the international eCTD standard in Ukraine.
Panel Discussion: eCTD Implementation — Experience and Outlook
A key highlight of the forum was a panel discussion focused on the practical aspects of eCTD implementation. Participants discussed progress, challenges, and next steps in rolling out this digital reform.
Key discussion highlights:
- Benefits of eCTD format adoption for applicants and regulatory bodies
- Results of the pilot phase:
• 173 applications submitted via the Ministry of Health’s Single Window
• 7 for initial registration
• 2 for re-registration
• 26 for variation submissions - Positive growth in participation from Ukrainian manufacturers
- Starting August 18, 2025, submission of new applications in eCTD format will become mandatory
Recommendations and Improvements
- Analysis of common documentation submission errors
- Practical tips for improving dossier quality
- Planned enhancements:
• Interface update of the Applicant’s Portal
• Expanded functionality of the Single Window
• Support for new application types (APIs, homeopathic products, magistral drugs)
• PSUR submissions in eCTD format
Conclusions and Gratitude
The PHARMEXPERT 2025 forum confirmed strong stakeholder interest in advancing digital regulatory standards in Ukraine. For iRIS Soft, participation marked another important step in fulfilling its mission — to promote transparency, efficiency, and compliance with European regulatory requirements in the pharmaceutical registration process.
We extend our sincere thanks to the organizers for a well-executed event and an inspiring professional atmosphere!
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