Ministry of Health: eCTD format now mandatory for new medicine registrations

Ukraine is continuing to implement the international electronic standard for submitting registration materials for medicines, known as eCTD (electronic Common Technical Document). As of 18 August 2025, all companies submitting documents for the new registration of medicines must do so in the eCTD format.

This requirement is stipulated by the Law of Ukraine “On Medicines” dated 28 July 2022, No. 2469-IX.

From now on, all documents must be submitted in a unified structure and in a format convenient for experts. This makes materials easier to review, faster to process, and simpler to track changes.

“The transition to the international eCTD format is another crucial step in the digitalisation of the pharmaceutical sector and alignment with European standards. It makes the medicine registration process more transparent and straightforward. Despite the challenges of wartime, thanks to the coordinated efforts of all stakeholders, the implementation of eCTD in Ukraine has been significantly faster than in other European countries,” emphasised Deputy Minister of Health for Digital Development Mariia Karchevych.

According to the State Expert Centre of the Ministry of Health, as of the start of the mandatory phase, 72 eCTD dossiers have already been submitted, including:

• 18 for the initial registration of medicines;
• 5 for re-registration;
• 49 for amendments to registration materials.

Additionally, 343 electronic applications have been received through the new “Single Window” functionality (applicant’s portal).

All details and instructions for working with the new format are available on the website of the State Expert Centre of the Ministry of Health of Ukraine via the provided link.

Background

The electronic Common Technical Document (eCTD) is a standard used in many countries worldwide for submitting technical and regulatory documentation during medicine registration procedures. Developed by the International Conference for Harmonisation (ICH), it unifies the format for information exchange between market participants and regulatory authorities.

The eCTD standard is successfully applied in Europe, the USA, and by regulators in countries such as Australia, Canada, Bahrain, Qatar, Kuwait, the UAE, Oman, Saudi Arabia, Japan, and others.