Background and Significance of eCTD
The Electronic Common Technical Document (eCTD) is an international standard for submitting regulatory information to health authorities.
It provides a harmonized format for pharmaceutical companies to submit applications, renewals, and variations for medicinal products.
Ukraine’s adoption of eCTD aligns with its goal to align regulatory practices with the EU, facilitating easier submission processes and enhancing regulatory efficiency.
Timeline for eCTD Implementation in Ukraine
Ukraine is implementing eCTD through a phased approach:
- August 2022: Law No. 2469 “On Medicines” passed, mandating eCTD implementation
- May 1 – Dec 31, 2024: Test period for new drug registration submissions
- July 1 – Dec 31, 2024: Test period for renewals and variations
- Jan 1 – Aug 17, 2025: Voluntary eCTD submissions allowed
- August 18, 2025: Mandatory eCTD submissions begin for all regulatory procedures
Key Steps for Pharmaceutical Company Preparedness
Technical Readiness
- Implement validated eCTD publishing software
- Ensure software compatibility with Ukrainian regional requirements
- Test internal systems and processes for eCTD creation and submission
Personnel Training
- Educate regulatory affairs staff on eCTD structure and requirements
- Provide hands-on training with eCTD software
- Familiarize team with Ukrainian-specific guidelines and validation criteria
Participation in Test Period
To join the test phase, companies should:
- Confirm internal technical readiness
- Send an official letter to digital@moz.gov.ua and dec@dec.gov.ua specifying:
- Proposed start date for test submissions
- Types of procedures to be submitted (e.g., new registrations, renewals)
- Contact person details for communication
eCTD Structure and Specifications
For those new to eCTD, it’s important to understand its basic structure:
- 5 modules organizing pharmaceutical, preclinical, and clinical information
- Module 1 contains region-specific administrative information
- Modules 2-5 are common across all regions
Key Ukrainian eCTD specifications include:
- Based on ICH eCTD v3.2.2 specification
- Utilizes Universally Unique Identifier (UUID) for dossier lifecycle management
- 95 validation rules, largely aligned with EU requirements
- Technical constraints:
- Maximum individual file size: 200 MB
- Folder name character limit: 64
Validation Process Explained
eCTD submissions undergo a multi-step validation process:
- Technical validation by applicant’s software before submission
- Technical validation by regulatory authority upon receipt
- Business rule validation by regulatory authority
- Content validation by regulatory assessors
- Scientific evaluation of dossier content
Failed validation at any stage may require correction and resubmission of the eCTD sequence.
Software Considerations
When selecting eCTD software, consider:
- Compliance with ICH and Ukrainian specifications
- User-friendliness and workflow integration
- Vendor support and update frequency
- Ability to handle multiple regions (for companies submitting to various markets)
Regular software updates may be necessary as Ukrainian eCTD requirements evolve.
Baseline Submissions and Lifecycle Management
- Baseline submissions (re-submission of previously approved dossiers in eCTD format) are voluntary but recommended for simplified lifecycle management
- After initiating eCTD submissions for a product, all future regulatory activities must use eCTD format
Future Developments
- Ukraine plans to eventually transition to eCTD v4.0. First will implement the current software version and correct any local technical issues. In future, the transition to v4.0 will be implemented “in the background” and should not be noticed by pharmaceutical companies.
- Regulatory professionals should stay informed about potential changes to Module 1 requirements or validation criteria
Industry Perspective: Delta Medical’s CEO on eCTD Implementation in Ukraine
The transition to eCTD in Ukraine represents a significant step forward for the pharmaceutical industry in the region.
While the initial implementation may present challenges, we at Delta Medical are confident that this move will ultimately streamline our regulatory processes and enhance collaboration with our international partners.
As a company that manages regulatory submissions for over 100 pharmaceutical firms, we anticipate that eCTD will simplify our work considerably.
Moreover, with other Eurasian countries also planning to adopt eCTD, we foresee creating greater synergies across our regulatory activities, thereby increasing our overall effectiveness and reducing the potential for errors and delays.
This harmonization will undoubtedly benefit not only our operations but the entire pharmaceutical industry.
Delta Medical is a leading pharmaceutical services company based in Switzerland, specializing in regulatory affairs and market access solutions.
The company operates across multiple countries in Europe and Eurasia, providing crucial regulatory support to pharmaceutical companies seeking international market expansion.
