On 22 May 2026, the State Service of Ukraine on Medicines and Drugs Control held a round table with the participation of relevant institutions and experts concerning the unification of approaches to the medicine quality control. This event was held in accordance with the Protocol of the meeting chaired by the Minister of Health of Ukraine on 15 May 2026, in order to discuss the interaction of the SMDC of Ukraine with laboratories authorized to carry out work on medicine quality control, including the use of standard samples for the state control of medicine quality control.
The meeting was attended by representatives of the Ministry of Health of Ukraine, specialists of leading scientific organizations and institutions in the field of medicine quality control.
During the round table, the general requirements and unification of approaches to laboratory testing were discussed, in particular the use of standard samples for analyzing the medicine quality, the need to ensure their metrological traceability, consistency with pharmacopoeia requirements and principles of standards and guidelines, namely: ДСТУ ISO/IEC 17025:2017 "General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2017); WHO guidelines "WHO good practice for pharmaceutical control laboratories" (WHO TRS No. 1052, 2024, Annex 4); EDQM recommendations for the OMCL network "Handling and Use of Non-Compendial Reference Standards in the OMCL Network", PA/PH/OMCL (11) 204 R9); Ministry of Health of Ukraine guideline СТ-Н МОЗУ 42-4.0:2020 "Medicines. Good manufacturing practice".
As a result of the round table, with the aim of applying a single unified approach to the use of standard samples by laboratories for the medicine control, it was decided to approve the Instructions for assessing the suitability of standard samples and general recommendations on the principles of their traceability for use by laboratories involved in the state control of the medicine quality control.