Answers to Frequently Asked Questions

The objective of the reform is to establish a strong, independent, transparent, and modern regulatory authority. Its activities will contribute to:

• Quality, safety and affordability of medicines,

• Alignment with the EU legislation,

• Enabling investment climate,

• Competitiveness of pharmaceutical industry,

• Development of pharmaceutical innovations.

The State Control Authority is a newly established executive body with a special status that will provide services and carry out oversight in the pharmaceutical sector. The Authority will be responsible for the full lifecycle of medicinal products — from manufacturing and import to distribution and dispensing in pharmacies.

• Medicines 
• Medical devices
• Blood and blood components
• Narcotic drugs, psychotropic substances and precursors 
• Cosmetics 
• SoHo (substances of human origin)

The State Control Authority will become operational on 1 January 2027. 

Throughout 2027, a transition period will be in place, during which the institutional setup of the Authority will be completed, including staff recruitment, regulatory framework development, technical capacity building, and the transfer of archives from the State Expert Center and the State Service of Ukraine on Medicines and Drugs Control.

During this period, the new Service will already perform its core functions, including making decisions on the registration of medicinal products. In parallel, the State Expert Center will complete the assessment of applications submitted by 31 December 2026, ensuring continuity of services.

The Authority operates under the oversight of the Cabinet of Ministers of Ukraine, through the Minister of Health.

The SCA will operate under a mixed funding model, combining allocations from the state budget with contributions from market participants. This approach reflects the practice used in most EU countries and supports the financial sustainability and institutional independence of the regulator.

Funding from market participants will include mandatory payments, in particular:

• pharmacovigilance fee 

• a fee for access to a personal account in the pharmacovigilance database;

• contributions to the implementation of state surveillance (control) activities.

The amounts of these contributions, fees, and service charges will be determined by the Government using a dedicated methodology and reviewed on an annual basis. This approach allows for consideration of the needs of both the state and the market, while ensuring predictability and sustainability of funding.

The Head of the SCA will be selected through an open and competitive selection procedure. Clear eligibility criteria will apply to candidates, including:

• integrity;

• experience in management;

• leadership skills.

Following the appointment, the Head’s performance will be assessed annually by the Civil Oversight Council. A negative evaluation may serve as grounds for dismissal. This approach ensures transparency, accountability, and the independence of the SCA’s leadership.

Staff of the SCA will be recruited in accordance with clearly defined qualification requirements for each position. Recruitment procedures will depend on the legal framework in force:

• After the end of martial law, all staff will be recruited through open competitive selection.

• During martial law, staff from the State Expert Center and the State Service of Ukraine on Medicines and Drugs Control may be appointed, provided that:

  • candidates meet all qualification requirements;

  • appointments are not automatic and each case is considered individually.

In all cases, the SCA aims to form a professional and trustworthy team capable of working under the new regulatory framework in line with EU standards.

During the war, the number of counterfeit, substandard, and illegally imported medicines in Ukraine has increased significantly. In 2024 alone, 320 decisions banning such medicines were issued, which is 2.7 times more than in 2023. This highlights the urgent need to strengthen control. Addressing this challenge will be one of the key tasks of the new SCA, which will become operational on 1 January 2027.

The SCA will act as a single regulator in the pharmaceutical sector and will be responsible for the entire lifecycle of medicinal products — from registration, manufacturing, and import to distribution and sale in pharmacies. Unlike the current fragmented system, this model will concentrate responsibility within one authority and allow for a faster response to risks, including those related to counterfeit medicines.

For the first time, draft legislative amendments introduce a clear legal definition of counterfeit medicinal products. Once these changes are adopted, the SCA will have the necessary legal powers to effectively control and address such products.

The SCA will also have a strong inspection service, with an adequate number of qualified specialists and proper funding. This will enable regular inspections of pharmacies, warehouses, and suppliers, as well as oversight of online sales, where counterfeit medicines most often appear.

Official online pharmacies will be marked with a special logo — “Legal online pharmacy”. Purchasing medicines from websites without this label will be done at the consumer’s own risk.

At the same time, the state will carry out public information campaigns to raise awareness about safe and legal channels for purchasing medicines.

Another important tool will be the introduction of 2D coding on medicine packaging — a digital barcode that allows consumers to verify the authenticity of a product. This system will be implemented in stages: on a voluntary basis from 2026 and mandatory from 2028 for medicine manufacturers in Ukraine.

These digital solutions will provide citizens with a simple and reliable way to check medicines before purchase, which is especially important given the growing risks of counterfeit products.

No. The establishment of the SCA will not affect the price of medicines. According to estimates by the international analytical company Proxima Research, the financial burden of business-related fees will account for only 0.5–1% of the annual turnover of the pharmaceutical market. This level is too low to have a meaningful impact on the final price of medicines.

The SCA’s mixed funding model, which combines contributions from businesses with state budget funding, will ensure the Service’s financial stability and independence. This approach is widely used in EU countries, including by the European Medicines Agency (EMA).

Most importantly, the new system will guarantee the quality, safety, and transparency of the circulation of medicines in Ukraine. This is also in the interest of businesses themselves. By operating under clear and transparent regulatory rules and gaining opportunities to expand their export potential, companies will pay for a high-quality regulatory service that directly supports their development. This is not about shifting costs onto consumers, but about business investment in transparent European rules that strengthen trust and support market growth.

During wartime, the state must demonstrate its ability not only to defend the country, but also to build for the future. The war has not stopped patients who need safe and affordable medicines, nor manufacturers who seek to operate in a transparent market and enter new markets. Ukraine’s commitments to the European Union have also not been put on hold. It is therefore logical to implement a long-overdue regulatory reform at this time.

First, there is an economic dimension. Building a modern pharmaceutical regulatory service is a pathway to GDP growth, job creation, new investment, and access for Ukrainian companies to international markets. If Ukraine aims for full EU membership, it must be ready to operate under shared rules — and this requires the establishment of an independent regulator based on the EU model.

Second, there is a reputational dimension. Even during a full-scale war, Ukraine demonstrates its ability to implement complex and systemic reforms. This helps build trust in the state among international partners — and trust is what opens European markets for Ukrainian manufacturers and supports the attraction of foreign investment. A transparent, professional, and independent regulatory service is one of the key indicators of such trust.

Third, there is a strategic dimension. Readiness for EU membership is measured not by political statements, but by concrete actions, including alignment with European Union legislation (the EU acquis). Brussels does not expect Ukraine to wait until the end of the war to implement reforms. On the contrary, it expects real capacity to operate in line with European standards even under extremely challenging conditions. The establishment of the SCA is a clear demonstration of this capacity.

The European Commission has already highly assessed Ukraine’s progress in the field of healthcare. In April 2025, it confirmed that Ukraine is fully aligned with the EU acquis in the area of blood and partially aligned in other areas, including medicinal products, cosmetics, and mental health.

The next step is to complete the reform by launching the new regulatory service, which will enable full integration into the European regulatory system for medicinal products, medical devices, cosmetics, precursors, blood, and substances of human origin (SoHO).

While Ukraine’s defenders are fighting for the country’s future on the battlefield, the state must do everything within its power to ensure that this future is firmly anchored in the European Union.

The establishment of the new State Control Service is not only about regulation, but also about creating new professional opportunities in Ukraine, particularly for young people.

For students and graduates of medical and pharmaceutical programmes, the SCA offers an opportunity to work in a public institution operating in line with EU standards. Already at the launch stage, the SCA plans to announce open competitions for dozens of analytical, regulatory, and inspection positions, with transparent conditions, opportunities for professional growth, English-language vacancies, internships, and training.

For young professionals, working at the SCA means access to modern approaches to pharmaceutical regulation, cooperation with European counterparts, an understanding of EU procedures, and a real opportunity to contribute to systemic change in the country.

This will serve as an additional incentive for young specialists to remain in Ukraine and build their careers domestically rather than seeking opportunities abroad. For the state, it is an investment in a new generation of professionals who will help strengthen trust in public institutions and in the healthcare system as a whole.

The establishment of the SCA is an important step towards integrating Ukraine into the EU’s common regulatory framework. The new Service is being designed in line with European models and with the involvement of experts from EU Member States. In particular, an 18-month Twinning project will be implemented in Ukraine, under which EU experts will support the harmonisation of legislation in the field of medicinal products, the development of new procedures, and the training of the future regulatory team.

The presence of an independent regulator compliant with EU requirements will open the way for the mutual recognition of GMP certificates, marketing authorisations, and other regulatory documents between Ukraine and the EU. In the longer term, this will make it easier for Ukrainian manufacturers to enter the EU market, reduce export barriers, and strengthen Ukraine’s role in ensuring the supply of critical medicines in emergency situations.

The launch of the SCA sends a clear signal to European partners that Ukraine is moving towards shared EU pharmaceutical rules and is ready to operate as an equal partner in the European market.

Independent oversight, clear rules, and safeguards against abuse are the core principles of the new SCA. The Service is being established as an open and accountable institution that operates in the public interest.

The Head of the SCA will be appointed exclusively through an open competition, based on clear requirements related to professional experience, leadership skills, and integrity. The Head’s work will be subject to two independent oversight mechanisms:

• The Civil Oversight Council, composed of nine public representatives approved by the Cabinet of Ministers of Ukraine, will have the authority to assess the Head’s performance. A negative assessment constitutes formal grounds for dismissal.

• The External Control Commission, comprising representatives of the Verkhovna Rada of Ukraine, the Cabinet of Ministers of Ukraine, and the Ministry of Health, will conduct annual evaluations of the Service’s effectiveness and transparency. All results will be made public.

Clear conflict-of-interest rules will apply: employees of the SCA may not have personal or financial interests in the pharmaceutical sector they regulate. All staff will be required to submit annual declarations of interests.

To prevent risks during the transition period, the involvement of the State Expert Center and the State Service of Ukraine on Medicines and Drugs Control is предусмотрено, ensuring institutional continuity and minimizing potential gaps in oversight.

Taken together, these mechanisms form a modern and transparent regulatory system that builds trust among citizens as well as international partners.

The establishment of the State Control Authority (SCA) based on the European regulatory model will enable Ukraine to become a reliable partner for EU regulatory bodies. This allows Ukraine to:

• Participate in joint audits, assessments, and inspection missions together with EU regulators;

• Join joint grant initiatives, including programmes such as EU4Health and Horizon Europe, in partnership with European agencies;

• Implement innovations in cooperation with European partners — ranging from digital solutions to new systems for quality control and data exchange.

On the contrary. At present, pharmaceutical regulation in Ukraine is divided among three institutions: the Ministry of Health makes decisions on the registration of medicinal products based on assessments conducted by the State Expert Center, while the State Service of Ukraine on Medicines and Drugs Control carries out inspections, issues licences, and oversees product quality on the market. This fragmented model disperses responsibilities and prolongs regulatory procedures.

The establishment of the State Control Authority (SCA) will consolidate these functions within a single Authority, following a model already in place in the EU. This will reduce duplication, streamline procedures, accelerate decision-making, and provide clear, transparent, and predictable rules for businesses.

In addition, harmonisation with EU legislation will make it easier for Ukrainian pharmaceutical manufacturers to export their products to the EU market.

In the longer term, pharmaceutical reform is a key step towards a so-called “pharmaceutical visa-free regime” — the extension of the Agreement on Conformity Assessment and Acceptance of Industrial Products (ACAA) to medicinal products. This would enable trade between Ukraine and the EU to take place under the same conditions as between EU Member States, without the need for additional certification.

Yes. The establishment of the State Control Authority (SCA) is not only about service provision — it is about fair and uniform rules for all market participants. The new Authority will operate through transparent procedures, clearly defined criteria, digitalised processes, and publicly accessible registers.

No company will receive preferential treatment or a “special status”. On the contrary, regulatory equality will be a core advantage of the new system. Businesses will be able to plan their activities, invest, and scale with confidence, knowing the rules in advance and without the risk of discretionary decision-making or selective enforcement.

The SCA will ensure fair competition based on compliance, not on personal connections. This European approach will support market development, reduce corruption risks, and encourage innovation.

Under the future operating model of the State Control Authority (SCA), there will be two main sources of revenue from market participants: fees for services and annual charges and contributions. These payments will ensure the sustainable functioning of the SCA, as well as the development of its expert capacity, supervisory activities, and digital infrastructure.

Fees for SCA services

These are payments for specific actions initiated by market participants at their request. They include:

• assessment of registration dossier materials (for a new medicinal product or for variations to an existing registration);

• scientific advice on future registration;

• issuance of extracts from the State Register of Medicinal Products;

• other regulatory actions carried out by the SCA upon request of businesses.

Annual charges and contributions

These are fixed payments intended to support the SCA’s ongoing activities in quality control, supervision, and pharmacovigilance:

• state surveillance (control) charges, paid annually by:

  • manufacturers

  • importers

  • wholesale distributors

  • pharmacy chains

  • marketing authorisation holders

• annual pharmacovigilance charge — a fee for participation in the unified pharmacovigilance system coordinated by the SCA;

• pharmacovigilance IT system access charge (user account) — covering the maintenance of digital infrastructure and data exchange.

According to estimates by the international analytical company Proxima Research, the expected financial impact on businesses will not exceed 0.5–1% of the annual turnover of the medicinal products market. This represents a minimal cost burden, especially in light of the benefits of a streamlined regulatory system and the potential progress towards a “pharmaceutical visa-free regime” with the EU.

The establishment of a single State Control Authority is a clear signal of trust for international pharmaceutical companies. A transparent and independent regulator operating in line with EU standards means that all market participants are subject to the same rules, and that the regulatory system is clear, effective, and predictable.

International companies seeking to expand manufacturing or diversify their supply chains will be able to build mutually beneficial partnerships with Ukrainian manufacturers.

Ukraine’s pharmaceutical sector is one of the strongest in Eastern Europe. As of July 2025, 129 licensed industrial manufacturers of medicinal products operate in Ukraine (according to the State Service of Ukraine on Medicines and Drugs Control). In 2024, total pharmaceutical production amounted to nearly EUR 3.5 billion, according to data from the international analytical company Proxima Research. Ukrainian manufacturers have established a full production cycle for 37 critical medicinal products based on active pharmaceutical ingredients (APIs) also produced in Ukraine (State Service of Ukraine on Medicines and Drugs Control).

The pharmaceutical market infrastructure includes over 24,000 pharmacies, 76 e-commerce platforms, and mobile pharmacies operating in 17 regions of Ukraine, as well as 215 importers and 402 wholesale distributors (according to data provided by the State Service of Ukraine on Medicines and Drugs Control). This creates a broad, already functioning logistics network that is also integrated into TEN-T, the trans-European transport network.

Despite the war, the sector has remained resilient. In 2024, exports of medicinal products reached USD 227.8 million, representing a 20.6% increase compared to the previous year (according to data from SMD).

Ukraine has all the prerequisites to become an important contributor to the European system for the supply of medicinal products — particularly against the backdrop of shortages of critical medicines in the EU. In 2024, Ukraine joined the Critical Medicines Alliance (CMA), an initiative established by the European Commission to address supply shortages in the EU market. Ukraine is already represented in the CMA by the Ministry of Health and six Ukrainian pharmaceutical manufacturers.

The Ukrainian pharmaceutical sector has a full production cycle for 37 critical medicinal products, including the manufacture of active pharmaceutical ingredients (APIs). Ukraine not only produces finished medicinal products but also manufactures pharmaceutical raw materials, creating a closed and resilient production cycle within the country. This capacity continues to grow, positioning Ukraine as a reliable partner for the localisation and scaling-up of production of critical medicines for the EU.

Ukrainian laboratories are already integrated into key international quality assurance systems, including GEON (Global Evaluation and Outsourcing Network), the WHO Prequalification Programme (WHO PQ), and the European Directorate for the Quality of Medicines & HealthCare (EDQM).

Ukraine also operates a Central Quality Control Laboratory, which has been undergoing assessment by the European Medicines Agency (EMA) since 2024. The laboratory’s capabilities include testing of medicinal products in compliance with EU standards, carried out for the state, businesses, and international organisations.

As of 2025, Ukraine has a well-established system for training pharmaceutical professionals. The country is home to the National University of Pharmacy in Kharkiv, which enrols 3,443 students, as well as 13 universities with pharmaceutical faculties under the supervision of the Ministry of Health.

These higher education institutions educate and train specialists who form the talent pool for employment within the new State Control Authority (SCA), ensuring the availability of qualified professionals to support its effective and sustainable operation.

The new Authority incorporates systemic anti-corruption safeguards. 

• The Head will be appointed exclusively through an open and competitive selection process, with clear requirements regarding integrity, professional experience, and leadership qualities.

• A Civil Oversight Council consisting of nine representatives of civil society, approved by the Cabinet of Ministers of Ukraine, will be established and empowered to assess the Head’s performance; a negative assessment will constitute formal grounds for dismissal.

• In addition, an External Control Commission composed of representatives of the Verkhovna Rada of Ukraine, the Cabinet of Ministers, and the Ministry of Health will annually evaluate the Authority’s transparency and effectiveness, with the results to be publicly disclosed. 

• Conflict-of-interest rules will be introduced, prohibiting employees from having financial interests in the sectors under the Authority’s supervision, and requiring annual declarations of interests.

• A transitional involvement of the State Expert Center and the State Service of Ukraine on Medicines and Drugs Control is also envisaged to preserve institutional memory and prevent abuses during the transfer of powers. 

Collectively, these mechanisms are intended to ensure the independence, transparency, and public trust in the new Authority.

The new body is being established as a modern, efficient and independent State Control Authority (SCA), where professionalism, integrity and relevant experience are the key principles. The objective is a qualitative transition to regulation in line with EU standards, which is why particular emphasis is placed on building a strong and highly professional team.

The Head of the Authority will be selected through an open and competitive procedure. Candidates will be assessed not only on professional expertise, but also on managerial competence, integrity and leadership potential. The Head’s performance will be subject to annual independent evaluation by the Civil Oversight Council. A negative assessment may serve as grounds for dismissal.

During the period of martial law, staffing will take into account temporary constraints. The transfer of employees from the State Expert Center (SEC) and the State Service of Ukraine on Medicines and Drugs Control may be allowed only if candidates fully meet the established qualification requirements. Automatic transfers will not apply.

After the end of martial law, all appointments to the Authority will be made exclusively through open competitions, based on clearly defined qualification criteria for each position.

Overall, the staffing of the Authority will be based on transparent, merit-based selection. Experienced and motivated professionals will have a real opportunity to contribute to the development of a modern regulatory Authority and to continue their careers within a system that operates under clear, transparent and high EU standards.

The organisational structure of the new State Control Authority (SCA) is designed to ensure effective, transparent and comprehensive regulation across all areas within its mandate. These include:

• Medicines

• Medical devices

• Cosmetics 

• substances of human origin (SoHO), including blood and blood components.

A total of 1,317 staff members are envisaged within the State Control Authority (SCA) system, including the central office, territorial bodies and laboratories.

Central Office

The central office will include departments and units responsible for the following key functions:

Registration, pharmacovigilance and regulatory control of products on the market
These units will be responsible for the registration of medicinal products and medical devices, monitoring their safety (pharmacovigilance), as well as regulatory oversight of cosmetic products, narcotic drugs and precursors.

Inspection and authorisation activities

These functions will cover licensing and inspection of manufacturers, importers, pharmacies and laboratories, as well as quality control of products and oversight of the circulation of SoHO products.

Digital transformation and analytics

This function will ensure the digital modernisation of the SCA, including the introduction of electronic services for interaction with businesses and the public, development and maintenance of state registers and information systems, and the use of large-scale data for managerial decision-making (data-driven governance).

Approximately 45 staff members are envisaged in this area, including positions within the digitalisation department and the units responsible for state registers and information systems.

International cooperation and European integration
The State Control Authority (SCA) will cooperate with peer regulatory bodies in the EU, participate in the Heads of Medicines Agencies (HMA) network, and take part in joint audits, assessments, Twinning initiatives and other European programmes.

Legal support and internal control
This function will ensure legal support, internal audit and compliance, prevention of corruption, adherence to ethical standards, and the development and implementation of regulatory acts.

Communications and public engagement
The relevant unit will be responsible for transparency of the Authority’s activities, public information and openness, engagement with stakeholders and the media, as well as handling requests, appeals, and complaints.

Professional development and training
A dedicated unit will be responsible for staff training, development of professional competencies and provision of methodological support.

Leadership

The SCA will be headed by a Chair, who will coordinate the work of the First Deputy Chair and Deputy Chairs responsible for specific areas, including digital transformation, inspection, registration, legal affairs and communications.

Territorial units

A total of 25 territorial units are envisaged. These units will:

• not have separate legal entity status;

• ensure regulatory and supervisory presence at the regional level;

• respond to local challenges;

• provide convenient interaction with market participants.

The territorial units will employ 471 professionals. Depending on their scope of activity, territorial bodies will be classified as:

• large — up to 37 staff members;

• medium — up to 20 staff members;

• small — up to 14 staff members.

Laboratory infrastructure

The laboratory infrastructure will be responsible for:

• laboratory quality control of products;

• testing and analysis of samples;

• performance of state control functions.

The laboratory network is envisaged to employ 110 staff members, including positions within the central office and at the territorial level.

This organisational structure is aligned with EU best practices and ensures a transparent governance model, effective regulatory oversight, and the SCA’s readiness to respond promptly to challenges in the healthcare sector.

The laboratory infrastructure of the SCA will be established as a professional network with clearly defined functions, capable of ensuring quality control of medicinal products in line with European standards.

Structure of the new laboratory system

• 1 Central Laboratory — responsible for all types of testing, including state quality control of medicinal products.

• 1 Laboratory of Immunobiological Products and Pharmaceutical Analysis — responsible for quality control of vaccines; WHO prequalified.

• 1 Pharmacopoeial Centre — responsible for scientific activities and pharmacopoeial support; does not perform state control functions.

• 5 Regional SCA laboratories — located in Kyiv, Dnipro, Odesa, Kharkiv and Rivne; responsible for quality control of products on the market.

The laboratories will serve as the operational backbone of the SCA, enabling it to:

• ensure independent product quality assessment based on standardised methodologies;

• move from formal compliance checks to a risk-based approach;

• promptly detect and remove substandard, falsified or unsafe medicinal products from the market;

• maintain trust among international partners, as the Central Laboratory is a member of GEON (the European OMCL network), holds ISO 17025 accreditation, and is WHO prequalified.