On 18 August 2025, new rules for submitting documents for the registration of medicinal products came into force in Ukraine. From now on, applications for new registrations must be submitted exclusively in the international eCTD format, as stipulated by the Law of Ukraine “On Medicinal Products”.
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The eCTD format is the global standard for electronic exchange of registration materials. It is used in the EU, the US, Japan, Canada, Australia, the Persian Gulf countries and other states. It standardises the submission of documents, makes them more understandable for experts and significantly speeds up the verification and review process.
According to the State Expert Centre of the Ministry of Health, as of the start of the mandatory phase, 72 dossiers have already been submitted in eCTD format. Of these, 18 relate to the initial registration of medicinal products, 5 to re-registration, and 49 to amendments to the materials. In addition, 343 electronic applications have been received through the new “Single Window” functionality.
The Ministry of Health notes that the transition to the international format allows the Ukrainian registration system to be harmonised with European and global standards. This creates conditions for greater market transparency, simplifies access to medicines for patients and strengthens confidence in the Ukrainian healthcare system.
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