Official visit of HALMED representatives to Kiev and national regulatory bodies for medicinal products in Ukraine
27.02.2025
Representatives of the Agency for Medicinal Products and Medical Devices (HALMED), led by Head of agency prof. Siniša Tomić, visited Kiev from 19 to 20 February 2025 on an official visit to the Ukrainian national regulatory bodies for medicinal products. The purpose of the visit was to continue the previously established cooperation and to support the Ukrainian national regulatory bodies for medicinal products in the pre-accession activities, in order to assist Ukraine in fulfilling conditions for accession to the European Union.
The key point of the visit was the meeting on the topic of medicinal products legislation reform, to align it with EU legislation. The meeting was held on February 20 at the Ministry of Health of Ukraine. Representatives of the competent authorities of Ukraine expressed their gratitude for the realization of the meeting and the opportunity for an open discussion with colleagues from the regulatory authorities of the EU member states.
One of the most important planned steps on Ukraine's path to accession to the EU was presented at the meeting - the establishment of a new regulatory body for medicinal products, a State Control Authority (SCA) that will be named the Service of Medical Products Ukraine (SMPU). This regulatory body will conjoin numerous regulatory competencies that are currently divided between the Ministry of Health of Ukraine (MoH), the State Expert Center of the Ministry of Health of Ukraine (SECMoH) and the State Service of Ukraine for Medicinal Products and Narcotics Control (SMDC), with the aim of modernizing and improving the efficiency of the Ukrainian medicinal products regulatory system. It was emphasized that the establishment of a new regulatory body and the alignment with EU legislation is a complex process, which requires systematic work, continuous cooperation and support from European regulatory bodies.
Prof. Tomić presented the work of HALMED and the Republic of Croatia's experiences in EU accession as the last country to join. He drew attention to the challenges in the process before and after accession, the steps taken to align the legislation and organizational structure with EU requirements, and highlighted recommendations to Ukrainian institutions, including the fundamental message of the necessity and value of timely preparation. During his speech, Prof. Tomić emphasized:
The establishment of the State Control Authority (SCA) marks a crucial step in consolidating regulatory functions and ensuring the effective supervision of medicinal products and medical devices in Ukraine. The commitment of our Ukrainian colleagues to progress and implement these crucial reforms during this difficult period for their country is truly inspiring.
Prof. Tomić also underlined that HALMED's experts will continuously provide guidance on EU procedures, providing Ukrainian colleagues with the insights into best practices and regulatory framework, as well as sharing their experience gained during the transition period and after Croatia's accession to the EU. He also added that the great progress and exceptional efforts of Ukraine in aligning its legislation with the EU acquis communautaire have been recognized and that Ukrainian colleagues can expect the support from Croatian experts in the development of an efficient system and establishment of the new regulatory body.
Mykhailo Babenko, Director of the State Expert Center of the Ministry of Health of Ukraine (SECMoH), presented the history of the competent authority, main areas of jurisdiction, role, mission, organizational structure and the scope of work. Director Babenko also thanked the representatives of HALMED for providing assistance and support during the implementation phase of the eCTD (The electronic Common Technical Document). Furthermore, he presented the statistical data on marketing authorizations, clinical trials, pharmacovigilance and described the modus operandi of the pharmacovigilance system. He also spoke about international cooperation, as well as partnerships and achievements through such cooperation, and presented plans and goals for the future.
Maryna Slobodnichenko, Deputy Minister of Health of Ukraine, presented the future structure of the new regulatory body whose jurisdiction will include medicinal products, medical devices, blood products, narcotics, psychotropic substances, precursors, cosmetic products and substances of human origin (soHo). Deputy Minister Slobodnichenko presented the plan for the laboratory system, anti-corruption tools and financing plan for the new competent authority (70% from its own revenue, 30% from the state budget). Deputy Minister also announced the need for a Twinning project and highlighted the expected results from such cooperation.
Director of the State Service of Ukraine for Medicines and Narcotic Drugs Control (SMDC), Roman Isaienko, presented the structure and competences of the SMDC, spoke about the importance of mutual cooperation between authorities in Ukraine, international cooperation, and highlighted the most important challenges and future plans of the SMDC.
Representatives of the Polish regulatory authority stressed the importance of supporting Ukraine and expressed their willingness and commitment to continue providing expert support in developing a new regulatory body for medicinal products in Ukraine and aligning its legislation with the EU. They emphasized their continued support for their Ukrainian colleagues, visit of the Ukrainian representatives to Poland and the signing of a memorandum of cooperation. Also presented were the plans, priorities and slogan "Safe Europe!" of the current Polish Presidency of the Council of the European Union. Poland will also dedicate one day to the subject of supporting Ukraine as part of the meeting of the Heads of Medicines Agencies (HMA).
The meeting was attended virtually by representatives of regulatory bodies from France, Denmark and Sweden, who pointed out that Ukraine is facing a demanding task in developing a new regulatory body and expressed their support and readiness for assistance. The representatives also presented the functioning of the European Medicines Agency (EMA), the European Commission through committees and groups, the work of the HMA and other organizations important in the joint work of the network, as well as the importance of participating in the work of the network through those institutions.
As part of their stay in Ukraine, HALMED's representatives visited the SECMoH headquarters and the SMDC laboratory.
