The State Pharmacopoeia of Ukraine, version 3.0, is currently in development, aimed at aligning national pharmaceutical standards more closely with European quality benchmarks. The Pharmacopoeia Centre is actively engaged in the preparation of this new edition, incorporating recent updates from the European Pharmacopoeia (Ph. Eur.) and leveraging the practical insights gained from the Ukrainian pharmaceutical sector. The DFU 3.0 is planned to be published in two volumes.
The first volume will address the essential pharmacopoeia standards, including general provisions, analytical methodologies, specifications for materials and containers, reagents, general texts, monographs, and dosage form requirements. The subsequent volume will focus on national texts that reflect the unique aspects of Ukrainian pharmaceutical practice. A central tenet of the forthcoming edition will be the progressive alignment with the European Pharmacopoeia. Nevertheless, Ukraine will retain its specific requirements where they hold practical significance, particularly concerning medicinal herbal raw materials, herbal preparations, and specific analytical methods.
As for monographs on substances, the Pharmacopoeia Centre does not plan to systematically update the harmonized Ph. Eur. monographs included in the State Pharmacopoeia 2.0. However, if necessary, such monographs may be developed and included in the State Pharmacopoeia, including at the request of manufacturers.
Special emphasis will be placed on national monographs. A significant volume is expected, including for medicinal herbal raw materials, herbal preparations and certain types of vaccines.
Thus, the DFU 3.0 should be a balance between European harmonization and Ukrainian pharmaceutical practice. This will allow to simultaneously bring the requirements closer to the standards of Ph. Eur.