Dear colleagues, partners, friends!
Today my five-year journey as Director of the State Enterprise "State Expert Center of the Ministry of Health of Ukraine" comes to an end.
It has been an intense, responsible and truly historic period – for me personally, for the team of the Center and for the entire pharmaceutical sector of Ukraine.
I sincerely thank the team of the Center – professionals who worked every day for the quality, safety and availability of medicinal products. It is people who became the main value and the main result of this stage.
I thank Minister Viktor Liashko, the staff of the Ministry of Health of Ukraine, the country's leadership, colleagues in the regulatory field, as well as applicants, manufacturers, distributors and partners – for trust, dialogue and working together.
Special gratitude to our European and international partners – EMA, European regulatory agencies, international expert organizations.
Over these years we did not merely cooperate – we built trust, integrated European approaches and proved that Ukraine is capable of being an equal professional partner.
Together we have gone through the pandemic, we counter the challenges of the full-scale war and daily transform Ukraine's healthcare system, while preserving institutional capacity, professional dignity and a strategic course towards European integration.
Let me briefly focus on the key achievements of 2021–2025.
The most valuable asset is the team! People who think, take responsibility, stay calm, support each other and do real work for the country.
In these difficult years we have preserved the team, ensured safety, stable salaries and the development of the enterprise. We demonstrated financial resilience, growth of assets and responsible fulfilment of obligations to the state.
Despite the war and restrictions, we managed to retain the trust of sponsors and an unwavering priority – compliance with the international standard of Good Clinical Practice during clinical trials. In 2021–2025, the Center recommended for approval by the Ministry of Health of Ukraine 625 clinical trial protocols and 5767 substantial amendments. An important step was the launch of clinical trials of advanced therapy medicinal products, which became possible thanks to the developed legislative changes and new guidelines.
On the recommendations of the Center, over the past five years more than 3000 medicinal products have been registered in Ukraine. We provided technical and expert support for the creation of the National Price Catalogue and introduced eCTD faster than other European countries. Winning the "Project of the Year" nomination of the prestigious pharmaceutical award "Panacea 2025" became recognition of this work.
In the conditions of war, the pharmacovigilance system confirmed its ability to withstand challenges. Over five years, almost 100 thousand reports of adverse reactions to medicinal products were analysed, and almost 50,5 thousand were submitted to the WHO international database. This is the result of coordinated work, including by the Center's representatives in the regions.
We consistently improved the quality and transparency of control: 198 clinical audits of clinical trials and 76 audits of applicants' pharmacovigilance systems were conducted. Our experts joined EMA working groups – which is an important step in building trust between the Center and EMA.
Health technology assessment has become a real tool that helps the state make informed, rational and evidence-based decisions, contributes to the rationalization of procurement and expands patients' access to treatment. A state HTA conclusion has been prepared 151. On their basis, dozens of managed access agreements have been concluded for the treatment of priority diseases, 35 medicinal products have been included in the National List of Essential Medicines
Particularly important in wartime conditions has been the development and implementation of more than 30 new clinical protocols "Combat Trauma" according to NATO standards, as well as, for the first time, the development of rehabilitation care standards.
The laboratories were reorganized into a single Pharmaceutical Analysis Laboratory. We have preserved the capacity and quality of expert research, increased the volume of work and modernized the material and technical base.
More than 300 training events have been organized, the status of a CPD provider has been obtained, and the professional level of almost 3 000 representatives of the healthcare sector has been improved. This is an investment in the future of the industry.
Already during the war, more than 30 draft regulatory legal acts were developed to implement the new version of the Law of Ukraine "On Medicinal Products". In 2025, the Center's specialists joined the official EU screening of the compliance of Ukrainian legislation with EU law (Acquis communautaire). Ukraine received a high assessment in the field of healthcare. Comprehensive legal support was provided for the implementation of the Center's main tasks and economic activities.
The Center has become an active participant in the global regulatory community. We obtained membership in ICMRA and ICH, established cooperation with EMA, FDA and regulators of EU countries, and joined the European Commission's IPA Training programs and the Twinning project to create the future independent regulator of Ukraine's pharmaceutical sector. This is a strong foundation for the further development of the Center and the entire industry.
I am completing this stage with gratitude, respect and faith in the future of the Ukrainian pharmaceutical regulatory system.
Ahead are new formats of cooperation, new projects and new opportunities to create value for patients, the healthcare system and our State.
Thank you to each and every one who was part of this journey!
It was a great professional and human experience.
Until we meet again!
Respectfully
Mykhailo Babenko
