On November 30, 2023, in Kyiv, the Pharmaceutical Forum "PHARMEXPERT 2023" took place, dedicated to the discussion of the creation of a single National Regulatory Authority in the pharmaceutical sector of Ukraine (NRA) — a central executive body with a special status that implements state policy in the field of development, market authorisation, quality control, safety, and efficacy of medicines, as stipulated by the Law of Ukraine No. 2469-IX "On Medicinal Products". Among the participants were representatives of the regulatory bodies from Sweden, Croatia, Poland, France, and Ireland, representatives of the Ministry of Health of Ukraine, the State Expert Center, the State Service of Ukraine on Medicines and Drugs Control, the Ukrainian Scientific Pharmacopoeia Center for Quality of Medicines as well as pharmaceutical companies, pharmacy segment, pharmaceutical industry professionals, and educators. Deputy Director for Quality from the Ukrainian Scientific Pharmacopoeia Center for Quality of Medicines, Natalia Volovyk, participated in the event in a video conference format.
Representatives of European regulatory bodies and public organizations expressed their support for Ukraine in creating the NRA and readiness to provide it with the necessary advisory assistance while noting that this is a rather long journey, during which Ukraine must ensure zero tolerance for corruption and the highest level of transparency in decision-making, and align its legislative and regulatory framework with EU legislation, taking into account the national strategy for quality of medicinal products. They emphasized the need for fruitful cooperation with international and domestic organizations involved in ensuring the quality, efficacy, and safety of medicinal products, in particular, pharmacopoeias, and encouraged Ukrainian professionals to actively participate in the work of European committees and working groups.
Ukrainian government officials presented a vision for the new regulatory body – the Ukrainian Medical Agency (UMA), according to which the State Service of Ukraine on Medicines and Drugs Control is to be liquidated, and all its functions are to be transferred to the UMA, as well as some functions of the Ministry of Health of Ukraine and the State Expert Center. The UMA should independently enact legal acts and implement state policy in the pharmaceutical field, be transparent and financially independent, and be based on the rules and regulations of the EU. The new Ukrainian Medical Agency is expected to become operational in approximately a year and a half.
Forum participants generally supported the idea of creating the NRA but also raised several important issues. These included the lack of a clear concept and opportunities for broad discussion of the NRA, uncertainty about its structure and personnel selection criteria, unclear plans for the planned 100% self-financing and effective anti-corruption measures. Concerns were also raised about the future of laboratories and state enterprises under the management of the State Service of Ukraine on Medicines and Drugs Control, as well as potential risks to the import and export of medicinal products and other challenges that may arise during the reform process.
Participants stressed the importance of avoiding hasty decisions and underestimating Ukraine's national achievements in the field of pharmacy, to which the professionals of the Ukrainian Scientific Pharmacopoeia Center for Quality of Medicines have made significant contributions. They emphasized the need for a gradual transition and the integration of new functions to ensure stability and uninterrupted operation of the pharmaceutical sector.