The Ukrainian eCTD in a Nutshell

With the implementation of the eCTD format, Ukraine is making significant strides in modernizing its pharmaceutical regulatory processes. Here's a comprehensive look at the current status, timelines, and key requirements for eCTD in Ukraine.

Current Status and Timeline

The journey towards the eCTD format in Ukraine began almost two years ago with the enactment of Law 2469, which laid the foundation for eCTD adoption. The Ukrainian authorities decided on a phased implementation approach that allows stakeholders to transition smoothly and ensures adequate preparation time.

Significant milestones in this journey include:

• December 2023: Amendments were made to a 2005 foundational order, establishing the foundation for eCTD specifications and validation criteria.

• March 2024: Approval of the eCTD specification, DTD validation criteria, and other essential requirements.

• May 2024: The pilot phase commenced for initial marketing authorizations.

• July 2024: Expansion of the pilot phase to include variations and lifecycle submissions.

• End of 2024: Conclusion of the pilot phase, leading to voluntary eCTD submissions from January next year.

• January 2025: Voluntary use of eCTD submissions
  
  

• August 2025: Mandatory eCTD submissions for all applications in Ukraine.

Legal Foundations and Requirements

The legal framework for eCTD in Ukraine is robust, anchored by the law on medicinal products, which stipulates electronic submission in accordance with the ICH eCTD standard. Several orders, such as Order 460 and Order 1245, along with their amendments, provide detailed guidelines and validation criteria. These regulations also mandate the use of qualified electronic signatures (QES) complying with the PAdES standard - for selected documents within Module 1, ensuring authenticity and integrity.

Participation in the Pilot Program

The Ukrainian Ministry of Health encourages participation in the pilot program for those who are technically prepared. Companies need to have the necessary software to compile and validate Ukranian eCTD submission and should be ready to submit an official letter indicating their readiness, the date of joining, and a contact person.

Structure and Specifications of the Ukrainian eCTD

The Ukrainian eCTD format, while similar to the EU's Module 1, remains an independent regional format. It aligns with ICH eCTD standards but includes some unique elements to cater to local regulatory requirements. Key structural components include:

• Electronic Documents: Compliance with ICH eCTD rules, with additional documents such as cover letters and tracking tables specific to Ukraine.

• Module Structure: Minor variations in granularity compared to previous structures, now closely following the ICH granularity principles.

• File Naming and Formats: Adherence to specified file and folder naming conventions, with PDF as the primary file format and working documents in Word format.

eCTD Submission and Validation in Ukraine

Ukraine has developed a dedicated portal for eCTD submissions, currently available only in Ukrainian, with an English version forthcoming. Submissions are uploaded as zip files, with the portal providing validation reports detailing any errors. Key technical validation criteria include:

• Compliance with file and folder naming conventions.

• Size and format restrictions for individual files.

• Use of qualified electronic signatures for specific documents.

• Inclusion of a unique UUID (Universal Unique Identifier) for each dossier, ensuring traceability and integrity.

Preparing for eCTD

To ensure a smooth transition, companies are advised to:

• Familiarize themselves with the Ukrainian eCTD specifications and validation criteria.

• Participate in the pilot phase if technically ready.

• Prepare for the strongly recommended baseline submission, which involves resubmitting all approved documents in their latest status.

Managing Ukrainian eCTD – we’ve got you covered! 

Navigating the new eCTD requirements can be challenging, but our services and tools - eCTDmanager and EURSvalidator - are designed to simplify and streamline this process. 

With our Regulatory Submission Publishing Services, we offer comprehensive support as soon as the Ukraine specifications are available. Please note: Organizations that participate in the pilot phase can already address us – we are able to support your test submissions due to the capabilities of our very own eCTDmanager! 

eCTDmanager is a comprehensive solution that supports the entire lifecycle of an eCTD submission. From initial dossier creation to lifecycle management, eCTDmanager ensures compliance with all regulatory requirements. Key features include: 

• Intuitive Interface: Simplifies dossier assembly and review processes. 

• Compliance Assurance: Ensures all documents meet Ukrainian eCTD specifications, including. Pre-Validation within the solution. 

• Lifecycle Management: Facilitates easy updates and maintenance of regulatory submissions. 

With EURSvalidator we offer an essential tool for validating eCTD submissions before they are sent to the regulatory authorities. It checks for compliance with technical validation criteria and helps identify any issues that could cause delays. Key features include: 

• Comprehensive Validation: Ensures all submission elements comply with the Ukrainian eCTD standards. 

• Detailed Reports: Provides clear, actionable feedback on any validation errors. 

• User-Friendly: Easy to integrate into your existing workflow, ensuring efficient validation processes. 

The transition to eCTD in Ukraine is not just a regulatory update; it's a significant leap towards modernizing pharmaceutical submissions, improving efficiency, and aligning with international standards. By understanding the requirements and preparing ahead, pharmaceutical companies can ensure a seamless transition, avoid potential pitfalls, and gain a competitive edge in the market.
Embrace the change, equip yourself with the right tools, and be ready for the future of pharmaceutical submissions in Ukraine! 
 

We continuously support you in navigating the international eCTD landscape by providing a variety of free information, such as our white paper, “An Introduction to eCTD”. 
 
We also regularly conduct free webinars on eCTD-related topics (and much more!). If you'd like to receive invitations to these webinars and stay up to date with current developments, just go to Subscribe for EXTEDO Mailings | EXTEDO and subscribe to our free newsletter!