An analogue of the FDA will be established in Ukraine: what will change for patients from 2027

National Deputy Serhiy Kuzminykh proposed the creation of an independent drug regulator in Ukraine similar to the American FDA. According to him, such a regulatory body in the field of pharmaceuticals could be launched in 2027 after several years of preparation.

The national regulator must be legally independent and have a clear mandate, financial stability, staffing support and competencies, a pharmacovigilance system, IT infrastructure and other important aspects.

Among the expected benefits of creating such an agency are centralized quality standards, independent evaluations of drugs, effective risk response mechanisms, increased trust in medications, and faster implementation of competitive alternatives.

Ukraine should adopt the approach of creating an agency that directs industry development based on science, ethics, and transparency.

The establishment of an independent drug regulator in Ukraine could prove to be a step towards improving the quality and safety of medications for Ukrainian citizens, and will also contribute to integrating the Ukrainian system into European and global supply chains.