Ukraine is switching to the international electronic standard eCTD for drug registration

Ukraine has begun implementing the international electronic format eCTD (electronic Common Technical Document) for drug registration. This step is part of the comprehensive digital transformation of the healthcare system and adaptation to European regulatory standards for the pharmaceutical market.

According to the Government Portal, from March 2025, after the completion of the test phase, companies are allowed to voluntarily submit registration dossiers in the eCTD format. In a short time, the State Expert Center of the Ministry of Health of Ukraine has already accepted 31 dossiers in the new format. Of these, 6 were submitted within the framework of initial registration, 1 for re-registration, and 24 for amendments to already registered drugs.

In addition, 17 more dossiers are expected to be submitted in the near future, as well as an increase in the number of applications through the new digital document submission system - "Single Window". This functionality simplifies communication between pharmaceutical manufacturers and the regulator and speeds up the review of applications.

The initiative to transition to eCTD is actively supported by international pharmaceutical companies that already have experience working with this format. At the same time, Ukrainian manufacturers are also joining the process, seeking to meet the modern requirements of the global market.

Deputy Minister of Health for Digital Development Maria Karchevych explained the advantages of the innovation: "The eCTD format unifies the submission of documents, making the process transparent, understandable and effective for all participants. In addition, the electronic format significantly reduces the time required for processing and analyzing registration information."

The implementation of eCTD brings Ukraine closer to the standards of the European Medicines Agency (EMA), which not only improves the quality of regulatory processes, but also paves the way for the recognition of the Ukrainian pharmaceutical system at the international level. It is expected that the full transition to eCTD will become a mandatory stage in the development of the domestic industry in the coming years.