EU states continue to face shortages of critical medicines. The problem, which crystallized during the COVID-19 pandemic, remains relevant today. In 2024, 44% of French citizens reported experiencing medicine shortages. In 2023, Ireland simultaneously lacked over 300 types of medicines. In Germany, some pharmacies were forced to close due to supply disruptions. These examples show that even advanced healthcare systems are vulnerable to supply chain disruptions.
The European medicines agencies network has developed a joint strategy. One of its key priorities is to address the shortage of critically important medicines. To achieve this, the strategy includes:
Since 2022, Ukraine has held the status of an EU candidate country and is therefore adapting its legislation across numerous sectors. The process of European integration highlights the cross-sectoral nature of modern healthcare: the Ministry of Health of Ukraine participates in 21 out of 35 negotiation groups, ranging from transport policy and digital transformation to energy and regional policy.
Ukraine is gradually fulfilling the requirements for EU accession, particularly in the field of healthcare. The European Commission has published an assessment of Ukrainian legislation: there is full alignment with the EU acquis in the area of blood, and partial alignment in 13 other areas. Ukraine has also received support from the European Commission to join the platform of European market surveillance authorities for cosmetics (PEMSAC). Additionally, the European Commission is launching the final public consultation on a key act for the full implementation of the EU Health Technology Assessment (HTA) system.
One of the significant changes on Ukraine's path to the EU is the launch of a single regulator in the pharmaceutical industry. Maryna Slobodnichenko, Deputy Minister of Health of Ukraine for European Integration, has become the main public representative and driving force behind this reform. She is coordinating the process of establishing the new regulator at the government level.
In an interview with UkraineWorld, she explains why the update is necessary and what the Ukrainian pharmaceutical sector can offer the EU and the world.
Access to effective and safe medicines, oversight of their circulation, pharmacovigilance, and high-quality inspection are key components of the healthcare system. In Ukraine, these functions are currently distributed among several institutions. The Ministry of Health develops policy, registers medicines, and oversees clinical trials. The State Service of Ukraine on Medicines and Drugs Control is responsible for quality control, the safety of medicines, medical devices, and narcotic substances. The State Expert Center examines registration dossiers and carries out pharmacovigilance.
A new regulator in the pharmaceutical sector is being established based on the best practices of EU countries. Ukraine is integrating the experience, resources, and expertise already present in state bodies into this process. European experts are actively involved in developing the institution: as a result, the future regulator will have a modern structure, transparent processes, a digital foundation, and personnel independence in line with EU standards.
That is why active work is underway to establish a State Control Authority (SCA) in the pharmaceutical field. Its launch is scheduled for January 1, 2027.
The SCA is a state body with special status, directed and coordinated by Ukraine's government through the Ministry of Health. It will combine functions that are currently dispersed among several entities: from the registration of medicinal products to market surveillance, pharmacovigilance, licensing, and maintaining registries. The SCA's responsibilities will also include oversight of the production of medicinal products, medical devices, cosmetics, substances of human origin (SoHo), blood, narcotic and psychotropic substances, as well as control in the field of medical cannabis.
In developing its financial system, Ukraine used the cost-based approach of the European Medicines Agency (EMA), where part of the funding comes from service fees: nearly 70% of the new agency's budget will come from business contributions, while 30% will be state funding. Ukraine is also drawing on the experience of Poland, France, Denmark, and other EU member states, adapting proven regulatory practices to its own context.
The launch of the new agency is an important step in European integration and a chance for Ukraine to strengthen its position in the European pharmaceutical market.
"In general, the market for medical devices and medicinal products in Ukraine is quite large. There are over 15,000 registered medicinal products alone. 128 licensed industrial manufacturers of medicinal products operate in the country. 35 critically important medicines, which are in demand in the EU, are produced through a full production cycle. Our country has the potential to help the EU overcome the threat of medicine shortages and to become a pharmaceutical hub for the production of critically important medicines," explains Maryna Slobodnichenko.
At the same time, a transparent and comprehensible regulatory system creates opportunities for foreign investors who view Ukraine as a future platform for manufacturing and exporting within the EU.
The Ukrainian pharmaceutical sector continues to grow even under full-scale war. The export volume of medicinal products increased from $171.5 million in 2022 to $227.8 million in 2024 - a 33% rise over two years of active hostilities. This dynamic demonstrates that Ukraine's pharmaceutical industry is capable of ensuring a stable supply even under challenging circumstances. This is important for international partners seeking reliable suppliers for the European market.
A simple and transparent system of state oversight will also give foreign businesses greater confidence: investors will better understand the rules, processes will become faster, and risks will be reduced. The new agency being established in Ukraine will consolidate all key functions related to the registration, inspection, and supervision of medicinal products. This will replace the current complex system involving multiple institutions. For international pharmaceutical companies, this means:
Ukraine will become a more convenient entry point into the European pharmaceutical supply chain, for both investment and cooperation.
Key stages in the launch of the SCA are currently underway. On May 28, 2025, the European Commission announced a call for participation in the Twinning project to support the establishment of the new state control body in Ukraine. Twinning is an instrument designed to assist countries that are candidates for EU membership. EU experts will work alongside their Ukrainian counterparts to jointly develop procedures, documents, and new approaches to operations.
This is the first Twinning project in the healthcare sector and is intended to help harmonize legislation and develop the structure and policies of the future regulator. Maryna Slobodnichenko is the project leader on the Ukrainian side.
"The key goal of Twinning is to align Ukraine's pharmaceutical market regulatory system with EU standards. The outcome of the program will be the creation of a modern and effective regulatory system that meets EU standards," notes Slobodnichenko. "We are also working on self-assessment within the framework of the European Medicines Agency benchmarking procedure. This is a process for evaluating the national system for the circulation of medicinal products and vaccines according to EU standards. Our team will be trained to conduct such assessments, and starting from 2027, we plan to officially implement them. Experts from Poland and Croatia will assist us in this process."
Ukraine is already participating in EMA working groups and deepening cooperation with strategic partners in the pharmaceutical sector: Poland, Sweden, Denmark, Croatia, and France.
The establishment of the SCA is a step toward a complete overhaul of pharmaceutical regulation in Ukraine. This means a shift in approaches: European standards of control and registration, transparent processes, and a clear division of responsibilities. All of this is gradually bringing Ukraine closer to the EU regulatory model.
In the future, Ukraine will be able to apply for Stringent Regulatory Authority (SRA) status --- official WHO recognition that the regulatory system meets high international standards. This will open doors not only for expanding exports but also for Ukraine's new role as a partner for global players in procurement, market surveillance, and responding to health challenges.
"Our goal is to create a regulatory system that will be trusted by both Ukrainian patients and European partners. All of this is to develop opportunities for cooperation and the exchange of innovations," summarizes Maryna Slobodnichenko.
