Ukraine participated in the 182nd session of the European Pharmacopoeia Commission

Опубліковано 23.06.2025 о 14:47

The European Pharmacopoeia Commission (EPC) held its 182nd session on 17-18 June 2025 in Strasbourg. This session was attended by the delegation of Ukraine headed by Roman Isaienko, Head of the State Service of Ukraine on Medicines and Drugs Control. The delegation included representatives of the State Enterprise “Ukrainian Scientific Pharmacopoeial Center for the Quality of Medicines” and the State Enterprise “State Expert Center of the Ministry of Health of Ukraine”.

During the meeting, important aspects of improving pharmacopoeial standards were discussed, including the revision of a number of monographs,  as well as the texts of the German Homeopathic Pharmacopoeia. The participants also considered the pilot phase of a new approach – the publication of draft repeals of individual texts from the European Pharmacopoeia for open public discussion.

An important decision was made to update the general chapter 2.6.14 “Testing of bacterial endotoxins” and to include the method with Recombinant Factor C in the official analytical methods.

Also, the formalization of the course of abandonment of outdated and unethical testing methods – in particular, the use of histamine (Chapter 2.6.10) and depressants (Chapter 2.6.11) – has been completed. This course of abandonment of such approaches was launched during the 180th session at the end of 2024, and now it has been officially formalized in the Ph. Eur.

Special attention was paid to the issue of digitalization of the pharmacopoeia. Starting from the 12th edition, the printed version of Ph. Eur. will be completely discontinued, and instead it will be distributed exclusively in electronic format. This step will reduce the publication cycle to one year, ensure faster adaptation of changes and strengthen integration with national pharmacopoeias, including the Ukrainian one. At the end of the meeting, the participants had the opportunity to join the testing of the demo version of the online edition of Ph. Eur.12: to explore the possibilities of searching, viewing and commenting on pharmacopoeial articles and ordering pharmacopoeial reference materials.

In addition, the delegates supported the completion of the pilot phase of the development of quality standards for monoclonal antibodies (mAbs), which is being carried out within the framework of the Monoclonal Antibody Working Party (MAB WP).

The participation of the Ukrainian delegation in the work of the European pharmacopoeia community contributes to strengthening the role of Ukraine as a reliable partner of the European pharmaceutical community and is an important component of harmonization of national quality standards for medicines with European standards.

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