Meeting of the ЕВА with the Ministry of Health and the State Expert Center on the eCTD Testing Period

28/ 10/ 2024

Last week, the business community met with the Ministry of Health and the State Expert Center (SEC) to discuss the current status of the eCTD (electronic Common Technical Document) submission format testing period for registration dossier materials. At the meeting, representatives of the SEC team working on this project updated the pharmaceutical market on the number of companies participating in the testing period and highlighted the most common issues encountered. Olena Sytenok, the Health Care Committee Manager, emphasized the need to extend the duration of the eCTD testing period, given that only one company has passed validation in the system so far. Discussions also covered the potential delay in the full implementation of the system and the transition to mandatory use of the eCTD format for all business entities, as outlined by the new Law of Ukraine On Medicinal Products, which is scheduled for August 2025. The Committee has already submitted a request to the Ministry of Health and the SEC to extend the testing period and is hopeful for a positive response from the authorities. During the meeting, SEC representatives noted the potential to extend the testing period until March 1, 2025. However, in the Committee’s view, the testing period should continue until full testing of all processes (registration, re-registration, and submission of changes) has been completed by at least three companies, which would ensure adequate system testing from both the applicants and the regulatory authoritys perspectives.

At the meeting, representatives of the SEC team working on this project updated the pharmaceutical market on the number of companies participating in the testing period and highlighted the most common issues encountered.

Olena Sytenok, the Health Care Committee Manager, emphasized the need to extend the duration of the eCTD testing period, given that only one company has passed validation in the system so far. Discussions also covered the potential delay in the full implementation of the system and the transition to mandatory use of the eCTD format for all business entities, as outlined by the new Law of Ukraine “On Medicinal Products,” which is scheduled for August 2025.

The Committee has already submitted a request to the Ministry of Health and the SEC to extend the testing period and is hopeful for a positive response from the authorities. During the meeting, SEC representatives noted the potential to extend the testing period until March 1, 2025. However, in the Committee’s view, the testing period should continue until full testing of all processes (registration, re-registration, and submission of changes) has been completed by at least three companies, which would ensure adequate system testing from both the applicant’s and the regulatory authority’s perspectives.