REFORM OF THE REGULATORY
SYSTEM IN THE
PHARMACEUTICAL SECTOR

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)

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.

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.

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.

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.