Ukraine is entering the home stretch in establishing an independent state control body (ICB) in the pharmaceutical sector. It is scheduled to start its work on January 1, 2027, in accordance with the new Law "On Medicines". A transitional year for adaptation is also envisaged.

The UDC will become a central executive body with a special status. Its sphere of responsibility is the entire chain of circulation of medicines: from production and market authorization to quality control, safety and efficacy of medicines. It will also regulate medical devices, cosmetic products, narcotic drugs and psychotropic substances, substances of human origin (tissues, cells, including reproductive cells, and blood).

This reform is a strategic step towards integration into the EU pharmaceutical market. The need to harmonize the legislation with EU standards has been brewing for years, and real changes have become possible thanks to the partnership of the Ministry of Health of Ukraine, the European Commission and the European Medicines Agency (EMA).

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European integrationbrainstate regulationpharmaceutical industry