On 12 December 2023, the Center held a presentation of the Roadmap for Implementing eCTD in Ukraine for representatives of the pharmaceutical market. Specialists from the Ministry of Health, the Center, partners, and pharmaceutical market representatives – about 100 participants in total – joined the online meeting. The purpose of the event was to familiarize applicants with the developed roadmap, the next steps, and the timelines on the path to implementing eCTD in Ukraine.
The meeting was chaired by Mariia Karchevych, Deputy Minister of Health for Digital Development, Digital Transformation and Digitalization. The State Expert Center was represented by the Center’s Director Mykhailo Babenko, deputy directors and heads of structural units.
Head of the Center's Information Technology Department Artem Kleb gave a presentation. He presented the current status of eCTD implementation in Ukraine, the challenges, prospects, the roadmap and the key steps that must be taken for the successful integration of the standard. He also addressed some aspects of the test period, during which the involvement of applicants is planned.
Key benefits of implementing eCTD in Ukraine include:
- eCTD will make it possible to standardize the document submission format, which will make the process more transparent and understandable for all market participants;
- will speed up the processing and evaluation of registration materials, since the electronic format makes it easier to review and manage a large volume of information;
- will contribute to the unification of processes and standards between different countries, which is a key aspect in the context of globalization and international integration;
- minimizes the time and financial costs that traditionally accompany paper-based document flow;
- will have a positive effect on the environment by eliminating the use of paper.
Applicants had the opportunity to ask the organizers questions about the details of the transition to the new format, the specifics of submitting a dossier under the abbreviated procedure, state registration of APIs and other matters.
Based on mutual agreements, after a 2-3-week period needed to review the drafts of the documents provided (Specification, Validation Criteria), further discussions are planned on technical issues, regulatory framework, and organizational aspects of implementing eCTD in Ukraine.
