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News

Ukraine implements the international format for submission of a common technical document (eCTD) for registration of medicines

15 December 2023
120

The Ministry of Health is initiating another step in digitalization - the introduction of registration or re-registration of medicines in the eCTD format.

The eCTD format is an international standard for submitting registration materials in electronic form, which promotes transparency and efficiency. The introduction of the eCTD format continues as part of the implementation of European legislation in Ukraine.

What are the benefits of implementing eCTD in Ukraine?

  • the format for submitting documents will be standardized, making the process more transparent and understandable for all market participants;
  • the decision-making process for the registration of medicines will be accelerated, as the electronic format makes it easier to view and manage a large amount of information;
  • it will help unify processes and standards between different countries, which is a key aspect in the context of globalization and international integration;
  • it will reduce the burden of paperwork;
  • it will contribute to depaperization, as the previous paper-based format of document submission required the use of a large amount of paper.

A roadmap has been developed that envisages a phased launch with a test mode in 2024. Consultations with market representatives are also ongoing, and further steps towards the implementation of eCTD in Ukraine have been identified.

We invite you to join the discussion and add your suggestions for the implementation of eCTD in Ukraine.