The State Service of Ukraine on Medicines is to be abolished: who will now regulate medicines in Ukraine?
This was announced by the Ministry of Health and the State Service of Ukraine on Medicines and Drug Control. The Cabinet of Ministers adopted a resolution establishing the Ukrainian Pharmaceutical Agency on 4 June 2026.
A new body is being established in Ukraine to regulate the pharmaceutical market – the Ukrainian Pharmaceutical Agency. It is set to become the successor to the State Service for Medicines and Drug Control.
This refers to Cabinet Resolution No. 739 of 4 June 2026. The document provides for the establishment of the Ukrainian Pharmaceutical Agency as a central executive body with special status.
When will the new body begin operations?
The Ministry of Health has stated that the government’s decision creates the legal framework for the agency to commence operations on 1 January 2027.
Until then, the State Service of Ukraine on Medicines will continue to perform its functions. Once the new body is launched, it is the Ukrpharma Agency that will assume key powers in the field of state regulation of medical products.
What will the Ukrpharma Agency oversee
The new body will be responsible for state policy in the areas of the development, market authorisation, quality control, safety and efficacy of medicinal products.
The agency will also carry out market surveillance of medical devices, in vitro diagnostic devices, active implantable medical devices, bioimplants and cosmetic products.
Separately, the Ukrpharma Agency’s remit will include the circulation of narcotic drugs, psychotropic substances and precursors, combating their illicit trafficking, as well as issues relating to blood donation, blood components and the functioning of the blood system.
What will happen to the State Service of Ukraine on Medicines
The State Service for Medicines and Drug Control is set to be abolished.
Its functions are to be taken over by the newly established Ukrainian Pharmaceutical Agency. In other words, this is not merely a renaming exercise, but the creation of a new regulator as part of the pharmaceutical market reform.
Earlier, Deputy Health Minister Maryna Slobodnichenko stated that the Ministry of Health plans to abolish the State Service of Ukraine on Medicines and create a new regulatory body in its place. At that time, the name of the future regulator had not yet been announced.
Why is the Ukrainian Pharmaceutical Agency being created?
The Ministry of Health explains that the creation of the new agency is part of Ukraine’s European integration commitments.
The Ministry states that Ukraine must transition to a regulatory model aligned with the practices of European Union countries. In such systems, independent regulators are responsible for the control, registration and supervision of medicines and other medical products in accordance with safety, quality and efficacy standards.
In an international context, the Ukrainian Agency for Medicines, as envisaged by the Ministry of Health, is set to become a platform for regulatory innovation, the development of biotechnology, attracting investment and strengthening pharmaceutical production in Ukraine.
How the head will be selected
The next step will be to form a selection committee and hold an open competition for the post of head of the Ukrainian Medicines Agency.
The selection committee will consist of six members: three international experts and three representatives appointed by the Ministry of Health of Ukraine.
The Ministry of Health emphasises that the selection of the head of the new body must take place through a transparent competitive procedure.
What is expected from the reform
The government expects that the activities of the Ukrainian Medicines Agency will improve patients’ access to modern and innovative medicines.
The new agency is also expected to ensure effective regulatory oversight of medical products throughout their entire lifecycle, boost confidence in the quality and safety of medicines and medical devices, and help Ukraine integrate into the single European regulatory space.
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