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In 2025, the pharmaceutical market of Ukraine is making an important step towards digitalisation, the country is gradually transitioning to the use of the eCTD (Electronic Common Technical Document) format for the submission of registration dossiers for medicinal products. This format has long been successfully used in the EU, USA, Canada, and other countries and has proven to be an effective tool for electronic submission, updating, and maintenance of dossiers in compliance with international standards.
The transition to the eCTD format is stipulated by the Law of Ukraine “On Medicinal Products” No. 2469-IX dated July 28, 2022. According to this law, starting from August 18, 2025, submission of documents for state registration, re-registration, and amendments to the registration dossier in eCTD format will become mandatory.
In this regard, the Ministry of Health of Ukraine has approved technical requirements and specifications for the eCTD format (Order No. 691 dated April 23, 2024), which regulate the structure and rules for dossier submission in this format.
To ensure timely preparation and submission of registration dossiers for medicinal products in accordance with the new standards, we offer our professional support.
Need help with an eCTD dossier?
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Our eCTD-related services
We provide a comprehensive range of services related to the preparation, adaptation, and submission of registration dossiers in eCTD format, as well as full support at all stages of the regulatory process. In particular, we offer:
- structuring of dossiers in accordance with eCTD format requirements (Module 1UA and Modules 2–5 ICH eCTD);
- support during submission to the regulatory authority and assistance with technical validation;
- consultations on eCTD format and ensuring compliance with both national and international requirements.
Specialised eCTD software
We have our own proprietary software that complies with the international ICH eCTD v3.2.2 standard and the Module 1UA specification approved by the Ministry of Health of Ukraine under Order No. 691 dated April 23, 2024 (with all amendments considered).
We also provide this software to other applicant companies, their representatives, and manufacturers for independent creation and management of eCTD dossiers.
Key features of the software:
- complete eCTD dossier generation;
- user-friendly interface with a tree-like navigation structure;
- utomated creation of the UA envelope for submission to the State Expert Center of the Ministry of Health of Ukraine;
- tools for file archiving and import;
- ability to create additional branches within the eCTD structure.
The software also supports eCTD dossier validation and lifecycle management (responses to comments, amendments, re-registration).
If your company is preparing to submit a dossier in eCTD format or is looking for a reliable partner for its preparation, we are ready to offer the necessary support and technical solutions.
By working with us, you will gain access to high-quality and efficient eCTD dossier compilation at a reasonable cost.
For further information on our software or services, please contact us using the details provided on our website.
