Director of the State Expert Center of the Ministry of Health of Ukraine Edem Adamanov took part in the conference "PHARMBUDGET 2027", where he presented the vision of key regulatory changes awaiting the pharmaceutical market of Ukraine in 2027.
Within the block "Regulatory turbulence as a new form of stability", Edem Adamanov delivered a report "eCTD, state registration of medicinal products and preparation for implementation of the new Law of Ukraine "On Medicinal Products"".
The focus of the presentation was on three changes that will directly affect the work of applicants and the regulatory system: the transition to eCTD, the creation of the Ukrainian Pharmaceutical Agency and the implementation of the new Law of Ukraine "On Medicinal Products".
The Director of the Center paid particular attention to the transition to eCTD. This is not just a new format for submitting documents, but a different approach to working with regulatory data: the dossier has a single structure, a consistent history of changes and a managed lifecycle.
"eCTD is no longer a pilot project, but a working mode. And the main change here is not that paper is being replaced by an electronic format. The very logic of working with regulatory data throughout the entire lifecycle of a medicinal product is changing," noted Edem Adamanov.
For applicants, working in the eCTD format means transparency and predictability of procedures, and less duplication of information. For the regulator, it means structured data and faster navigation during expert evaluation. At the same time, eCTD ensures a unified approach to working with regulatory data, which is in line with the practice of European regulatory agencies.
The second area of change will be the formation of a new regulatory environment with the launch of the Ukrainian Pharmaceutical Agency. The new model envisages concentrating regulatory functions within a single responsible body – from clinical trials and state registration to pharmacovigilance, licensing, inspection and quality control. Today, these functions are distributed among several institutions.
"The main change is not a new sign. The main change is new logic," emphasized Edem Adamanov.
For market participants, such a model will mean a single entry point, harmonized requirements and clear responsibility for regulatory decisions. For the patient, it means consistent control of the quality and safety of a medicinal product throughout its entire lifecycle.
The third block – implementation of the new Law of Ukraine "On Medicinal Products". The Director of the Center emphasized the need to assess readiness for the new requirements in the field of state registration, clinical trials, bioequivalence, pharmacovigilance and import right now.
In particular, this concerns a single period of state registration of 210 calendar days, simultaneous submission of the application and the registration dossier, as well as a five-year period for bringing the dossier into compliance with the new requirements.
Edem Adamanov emphasized that market participants should use the time before the transition to the new rules for preparation: analyze their own portfolio, check readiness for eCTD, bring the marketing authorization holder into compliance with the new requirements and, if necessary, use scientific consultations even before submitting the dossier.
According to the Director of the Center, the success of the regulatory reform will be determined not by the number of adopted regulatory acts, but by its practical result – predictability of procedures, effectiveness of the regulatory system and timely access of patients to quality and safe medicinal products.
