The end of 2020 and the beginning of 2021 kicked off important changes at the State Expert Center of the Ministry of Health of Ukraine. The new director Mykhailo Babenko is introducing new approaches and principles in the work. Among the main strategic goals of the enterprise's development are digitalization, shorter expert evaluation times, simpler procedures and transparency of operations.
Mykhailo Mykolaiovych, you have headed the Center since November 2020. And although not much time has passed, there must already be results that can be shared. Especially considering that “COVID times” demand quick decision-making and often set the task to “do it yesterday”.
Mykhailo Babenko: Yes, the global pandemic and the challenges of the new reality require prompt and non-standard solutions from us. Over 2,5 months as head of the State Expert Center, we have audited the Center's activities, including IT, finance, personnel, tender procurement, guidelines and orders. Based on the results, we understood what needs to be improved in each individual area and drew up a plan of priority actions. Our tasks include implementing health technology assessment (HTA), developing a unified electronic platform for clinical trials, registration and pharmacovigilance of medicinal products, digitizing the archive of registration documents, modernizing electronic document management, increasing the competitiveness of laboratories, and many other important steps.
We have also analyzed the legislative framework on clinical trials, registration, pharmacovigilance, and HTA for compliance with European norms and with countries with strict regulation. Given that some laws in Ukraine were adopted long ago, there are certain inconsistencies. Starting with the Law "On Medicinal Products," which needs to be amended, through Cabinet of Ministers resolutions and MoH orders, to our internal guidelines approved by orders of the Center.
Therefore, today the Center, together with the MoH and the Committee on Health of the Nation, is actively involved in drafting several legislative acts. Our specialists constantly provide recommendations on the necessary changes that will facilitate the quick and effective implementation of legislation as close as possible to European legislation. Our goal is to harmonize the legislative framework in all areas.
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