The State Expert Center of the Ministry of Health of Ukraine took part in a meeting with Ukrainian pharmaceutical manufacturers on preparations for the launch of the Ukrainian Pharmaceutical Agency (Ukrpharmagency) and the transition to a new model of pharmaceutical market regulation.
The meeting was chaired by the Minister of Health of Ukraine, Viktor Liashko. It was attended by the Director of the Center, Edem Adamanov, the Deputy Minister of Health for European Integration, Vasyl Strilka, the Deputy Minister of Health, Yevhenii Honchar, and representatives of Ukrainian pharmaceutical companies.
For the Center, preparations for the launch of the new regulator include, in particular, readiness to work under the new rules in the field of expert evaluation of medicinal products. Therefore, during the meeting, special attention was paid to regulatory procedures that directly concern the Center's work: state registration and re-registration of medicinal products, amendments to registration materials, assessment of registration dossiers and the transition to new procedures.
"It is extremely important for us that the transition to the new regulatory model takes place in constant dialogue with all stakeholders and without disruptions for the pharmaceutical market," noted Viktor Liashko.
One of the key tasks of the transition period is to ensure the continuity of regulatory procedures. A change in the regulatory model must not lead to pauses in the review of applications and the conduct of expert evaluation of medicinal products. At the same time, it is important to preserve the professional staffing potential and the accumulated experience of the specialists who support these processes.
During the meeting, the proposed legislative changes aimed at bringing Ukrainian regulation closer to European approaches were also discussed. In particular, these concern reducing the period for assessment of the registration dossier from 210 to 180 calendar days, expanding the list of countries in which the reference medicinal product may be registered, as well as defining transitional provisions for market participants.
It is important that procedures initiated before the new legislation enters into force will not have to be undergone anew. If an application for state registration, re-registration or the introduction of changes is submitted before the new rules enter into force, its review will be completed under the legislation in force at the time of submission.
Representatives of the pharmaceutical industry voiced practical questions and proposals arising in the process of preparing for the changes. Their further elaboration will take place in a continuous dialogue between the MoH, the Center and market participants.
To continue systematic work, the parties agreed to hold such meetings twice a month. Regular dialogue will make it possible to promptly address practical issues and jointly develop solutions for a predictable transition to the new regulatory model.
The Center continues its preparations for work in the updated regulatory system, focusing on the quality of expert evaluation, the readiness of specialists for new requirements, and the continuity of procedures in the field of state registration of medicinal products.
