Establishing a new regulator in the pharmaceutical sector: outcomes of the EBA–MoH meeting

03/ 09/ 2025

On 27 August, the Health Care Committee of the European Business Association held a working meeting with Maryna Slobodnichenko, Deputy Minister of Health of Ukraine for European Integration. The main focus of the dialogue was the European integration of Ukraine’s healthcare system and the creation of a new State Control Body, which is due to start operating simultaneously with the entry into force of the new Law of Ukraine “On Medicinal Products” No. 2469-IX on 1 January 2027. For industry representatives, the establishment and operation of the SCB is a key issue, as it is expected to become the foundation of a modern regulatory system for medicinal products and medical devices, as well as an important step in preparing the pharmaceutical market for Ukraine’s future EU membership. Work is currently under way on developing a methodology for calculating contributions and fees, which, in the Committee’s view, should ensure a sustainable, transparent, and financially independent model for the SCB’s operation, proportionate to the country’s economic capacity and market needs. The participants exchanged views and agreed on common benchmarks in the following key areas: creating the SCB as the cornerstone of a modern supervision system; implementing the Twinning project as a tool for introducing best European practices; harmonising the regulation of circulation and production of medical devices with EU legislation. In addition, the discussion covered preparations for EMA benchmarking in 2027, as well as the stages of establishing the SCB and institutional matters (the competitive selection process for the SCB’s head and the recruitment of key staff, among others). The European Business Association sincerely thanks Maryna Slobodnichenko for her openness to dialogue, constructive approach, and readiness to take into account the business community’s proposals. Meeting participants expressed their commitment to continued effective cooperation to ensure that the new regulatory instruments for both the state and the market deliver tangible results and remain aligned with patients’ interests.

01/

For industry representatives, the establishment and operation of the SCB is a key issue, as it is expected to become the foundation of a modern regulatory system for medicinal products and medical devices, as well as an important step in preparing the pharmaceutical market for Ukraine’s future EU membership. Work is currently under way on developing a methodology for calculating contributions and fees, which, in the Committee’s view, should ensure a sustainable, transparent, and financially independent model for the SCB’s operation, proportionate to the country’s economic capacity and market needs.

The participants exchanged views and agreed on common benchmarks in the following key areas:

creating the SCB as the cornerstone of a modern supervision system;
implementing the Twinning project as a tool for introducing best European practices;
harmonising the regulation of circulation and production of medical devices with EU legislation.

In addition, the discussion covered preparations for EMA benchmarking in 2027, as well as the stages of establishing the SCB and institutional matters (the competitive selection process for the SCB’s head and the recruitment of key staff, among others).

The European Business Association sincerely thanks Maryna Slobodnichenko for her openness to dialogue, constructive approach, and readiness to take into account the business community’s proposals. Meeting participants expressed their commitment to continued effective cooperation to ensure that the new regulatory instruments for both the state and the market deliver tangible results and remain aligned with patients’ interests.