Independent pharmaceutical regulator: how Ukraine integrates EU standards into its own reform

Ukraine is approaching the establishment of an independent pharmaceutical regulator, which will start operating on January 1, 2027. The State Control Authority (SCA) is being established, an institution without which it is impossible to fully integrate into the European pharmaceutical market. And an important step towards "pharmaceutical visa-free regime" is free access of Ukrainian medicines to the EU market without additional certification.

The body will regulate medicines, medical devices, blood and blood components, narcotic drugs, psychotropic substances and precursors, cosmetics and SoHo (substances of human origin).

Today, the authority to control and register medicines in Ukraine is divided between several organizations. The UDC will unite them and create new opportunities for Ukraine and the European Union. Regulatory policy in line with EU standards will open the door for Ukrainian medicines to international markets, and strengthening oversight of drug safety and quality will make the system more reliable for consumers.

The reform is based on the best European practices. Ukraine is working in close cooperation with the European Medicines Agency (EMA) to launch the DMC and is studying the best practices of EU countries, including Poland, Sweden, Denmark, Croatia and France.

Let's take our closest neighbor, Poland. The regulator in the pharmaceutical sector there is the Office for the Registration of Medicines, Medical Devices and Biocidal Products . The authority is subordinated to the Ministry of Health. Its powers include issuing permits for medicinal products, medical devices and biocides (including veterinary products), approving and supervising clinical trials, maintaining official registers, etc. The department is financed from the state budget and revenues from license, registration and service fees from businesses.

Another example close to us is Croatia. Here, the role of the regulator is played by the Agency for Medicines and Medical Devices (HALMED). Similar to the Ukrainian UDC, which will take over the functions of several existing bodies, HALMED is the successor to the Croatian Institute for the Control of Medicines and the Croatian Institute for the Control of Immunobiological Products.

The agency has a broad area of responsibility: it issues registration certificates for medicines, conducts quality assessment and control, grants production permits, maintains registers of manufacturers, importers and distributors, and much more. The agency is funded by annual fees and payments for services from pharmaceutical market participants.

In France, the regulator is the National Agency for the Safety of Medicines and Medical Devices (ANSM). It exercises comprehensive control over the entire life cycle of medicines and medical devices: safety, efficacy, and quality assessment; granting marketing authorizations; inspection of production facilities, etc. The agency also controls cosmetic products and breast milk banks. ANSM's funding is combined – the state budget and contributions and fees from market participants.

The Medicines Agency (Lægemiddelstyrelsen) performs such functions in Denmark. Its powers include issuing permits to pharmaceutical companies, licensing medicines, supervising clinical trials, monitoring medical devices, etc. As in Poland, the agency's regulatory scope includes veterinary products. The agency is funded by 85-90% from fees paid by market participants and by 10-15% from the state budget.

Another agency that was studied when developing the model of the Ukrainian regulator was the Swedish Läkemedelsverket. It was its patterns that we used to develop the draft staffing structure of the UDC. Läkemedelsverket regulates and supervises the development, production, and sale of medicines, medical devices, and cosmetics. The agency also controls veterinary products and tattoo materials. The agency is funded by 70% from business fees and fees for services (authorizations, inspections, clinical trials, etc.).

By the way, the European Medicines Agency (EMA) works in a similar way, and is currently actively helping Ukraine prepare for the launch of the DCA. It is 91.5% funded by fees and charges for its services, and 8.1% by EU healthcare contributions. It is its methodology that was used to calculate the fees and charges to be applied by the new Ukrainian body.

As we can see, regulators in most EU member states have similar schemes of functioning. As part of the reform for the Ukrainian pharmaceutical market, we are borrowing the European model of an independent body, staffing structure, areas of control and mixed type of financing with a desire for self-sufficiency.

Countries are currently being selected for the Twinning project. As part of the project, European experts will work with the Ukrainian team to implement EU standards in the healthcare system. It will include harmonization of regulations in the areas of regulation of the UMC with EU requirements, development of an organizational model of the regulator, and staff training. We expect to announce the winner in August 2025. The twinning will last 18 months and will allow implementing the best practices of European agencies in the UMC.

We do not copy any of the models in full, but take the best decisions from the experience of our colleagues. The Ukrainian DMC should become an effective player in the European medicines regulatory system and gain the trust of citizens, business and international partners.