The Director of the State Expert Center of the Ministry of Health of Ukraine, Edem Adamanov, gave his first interview in the position to the professional publication "Weekly Pharmacy".
The material covers the transformation of the SEC, regulatory changes of 2026-2027 and preparing the market for the implementation of the new Law of Ukraine "On Medicinal Products".
Among the key topics discussed:
- retention and development of the expert team
- digitalization of procedures and expansion of the functionality of the applicant's cabinet
- implementation of eCTD and updating approaches to pharmacovigilance
- changes in the field of clinical trials
- new requirements for bioequivalence
- establishment of a state control body
Particular attention was paid to ensuring a balance between European integration requirements and the competitiveness of the national manufacturer.
According to the director, the Center's focus is on clear rules, predictable decisions and ongoing communication with the professional community.
The full text of the interview with the video version is available at the link https://www.apteka.ua/article/740489
