The weekly APTEKA published an interview with the director of the State Expert Center of the Ministry of Health of Ukraine, Edem Adamanov, devoted to the upcoming transformation of the pharmaceutical regulatory system and the practical issues currently facing the state and the pharmaceutical business.
One of the key topics of the conversation is the creation of the Ukrainian Pharmaceutical Agency and the transition to a new regulatory model. According to Edem Adamanov, preparations for the launch of the new body are ongoing, and the planned date for the start of its work is 1 January 2027.
At the same time, in his opinion, the transformation of the system should take place consistently, with clear transitional mechanisms and without creating risks for the continuity of regulatory processes.
An important place in the new system should be preserved for the expert capacity of the Center. The Center employs specialists who have accumulated experience over 10–20 years, and this potential, according to the director, must be preserved. The Center's expert evaluation covers not only the registration of medicinal products, but also pharmacovigilance, health technology assessment, standards and treatment protocols, and other areas.
Separately, during the interview, the transition of the pharmaceutical market to new European requirements was discussed. Given the scale of the market – about 12 thousand SKUs of finished medicinal products – this process cannot happen all at once. That is why the Center has already prepared a draft transition plan, which in the future should be formalized by a resolution of the Cabinet of Ministers of Ukraine. The document has been sent to relevant business associations for review and comments.
Dialogue with the pharmaceutical market remains an important component of this work. The Center reviews internal processes taking into account stakeholders' proposals, holds consultations and is ready to help companies address specific regulatory issues.
"My main message is very simple: first do your homework. And with questions that cannot be resolved on your own, come to the Center's experts," said Edem Adamanov.
Another area is shortening the timelines of regulatory procedures. According to the Director of the Center, the Center is already reviewing every stage of document processing and for certain processes works faster than is the case in the EU. The target indicator for certain procedures is 35 days, excluding the time for the applicant to prepare responses to comments.
At the same time, the patient must remain at the center of all regulatory changes.
"It does not matter at all to the patient what the new regulator is called. What matters to them is that quality and safe medicines are in circulation."
The full text of the interview with Edem Adamanov is available in the "Apteka Weekly" at the link https://www.apteka.ua/article/751999
