As Ukraine continues its journey toward modernizing its regulatory processes, the recent publication of draft documents by SECMOH (State Expert Center of the Ministry of Health) heralds a significant milestone in the adoption of Electronic Common Technical Document (eCTD) format for medicinal product submissions. With the test period set to commence from May 2024 until December 31, 2024, stakeholders are gearing up for a transformative phase in regulatory compliance.
The upcoming test period encompasses two key phases:
State Registration of Medicinal Products: From May to December 2024, applicants will have the opportunity to participate in the test period for state registration, streamlining the submission process and enhancing accessibility to regulatory authorities.
State Re-registration and Introduction of Changes: Starting from July 01, 2024, until December 31, 2024, stakeholders will navigate the test period for state re-registration and the introduction of changes to registration materials, facilitating agility in responding to evolving regulatory requirements.
Preceding the test period are crucial preparatory steps, including the introduction, preparation, and approval of specifications and validation criteria in alignment with UA Module 1 standards. Prospective participants are required to submit their intent to participate along with an official letter to the Ministry of Health by April 10, 2024.
Integral to the success of the test period is the collaboration with developers of eCTD software to ensure compatibility with UA Module 1 specifications. The culmination of software testing by May 1, 2024, marks a pivotal milestone in readiness for the trial phase.
Advantages of eCTD Implementation:
Quick Access to Dossiers: Expedited access to regulatory dossiers facilitates efficient review processes.
Enhanced Efficiency: Transitioning from paper to electronic documentation streamlines workflows and enhances productivity.
Improved Product Lifecycle Management: Centralized data management facilitates better oversight of product lifecycle stages.
However, alongside the benefits come challenges:
Disadvantages of eCTD Implementation:
Mandatory Baseline Submission: Mandated baseline submission poses challenges, particularly concerning material costs and timeline constraints.
Transition Period Constraints: Insufficient time specified in the law for market participants to transition to mandatory baseline submission presents logistical hurdles.
Looking ahead, the Law of Ukraine “On Medicinal Products” will mandate eCTD submission from August 18, 2025, for various procedures, including registration, re-registration, and introduction of changes.
While baseline submission remains voluntary during the test period and beyond, stakeholders are strongly encouraged to embrace the transition toward electronic submissions for enhanced regulatory compliance.
Draft documents and technical files pertaining to eCTD implementation are available for reference in the Applicant’s section, providing essential guidance for stakeholders navigating this transformative regulatory landscape.
For further information, stakeholders are encouraged to visit the APPLICANT’S SECTION.
For any further questions or if you need help in your Regulatory Operations, contact us at: [email protected]
