Transformation of the Ukrainian pharmaceutical market – new opportunities and potential Pharmaceutical Industry Review, September No 4 (97) 2023
the creation of a new regulatory body and a national system for the verification of medicines. We need to work on this now, so it may be worth reconsidering the timing of the law's entry into force. Another important area that we are actively working on is the new Law on Medical Devices, and the implementation of regulations on medical devices is also under active development. Work is underway to bring the regulation of dietary supplements closer to European integration.
How do you involve representatives of regulatory authorities from other countries?
Another promising industry is clinical trials. Ukraine has every chance of becoming a center for researching new drugs for international pharmaceutical companies. After all, our country has many attractive factors for sponsors: a developed and extensive clinical trials infrastructure, qualified personnel, a large pool of patients, and relative cost-effectiveness of conducting trials compared to other European countries. We strive to develop this area and that is why we plan to promote Ukraine as a place where clinical trials can be conducted safely and efficiently. The state has a dual interest in the development of clinical trials: firstly, it is an investment in the pharmaceutical industry and the Ukrainian economy, and secondly, it enables to expand access to innovative treatment, which is completely free of charge for Ukrainian patients within the framework of trials.
You have held many meetings with businesses and regulators. What requirements and suggestions should be taken into account in the first place? What changes to the legislation should be made?
20 BACK TO CONTENTS
My main tasks at the Ministry of Health are to address the issues of European integration of the healthcare system in line with EU norms and standards. As soon as we complete the self-screening procedure and understand which legal acts still needed to be implemented, we will start holding regular meetings with business representatives, international partners, and healthcare experts. Together we are working on a roadmap for the implementation of EU acts into national legislation, analysing all the benefits and risks of accelerating this process. Such contacts are very important for businesses to have time and opportunity to prepare for the new requirements and standards that apply in the EU, and for the Ministry of Health to solve all problems and take into account the nuances that the industry may face when all the innovations come into effect. By the way, thanks to such meetings, we also feel that we have a priority, for example, enforce several provisions of the new law "On Medicines". I would like to note that many important provisions contained in this law were frozen during the war. We are talking about
Currently, we have prioritized our efforts to establish cooperation not only with the regulatory authorities of other countries but also with the main EU institutions. In September, we plan to make our first working visit to Brussels and Amsterdam to meet with the relevant agencies and directorates of the European Commission, in particular the European Medicines Agency (EMA), the European Health and Digital Agency (HADEA), the Directorate- General for Internal Market, Industry, Entrepreneurship, Small and Medium-sized Enterprises (DG GROW) and the Directorate-General for Health and Food Safety (DG SANTE). Our objectives are to strengthen interaction and discussions on Ukraine's participation in the Instrument for Pre-Accession Assistance (IPA) program, exchange of experience and coordination with EMA committees, recognition of GMP certificates and simplification of regulatory procedures, transition of Ukraine to the electronic format of submission of registration dossiers for medicinal products (eCTD), and strengthening cooperation in conducting clinical trials. We are also planning to discuss the creation of a single regulatory authority to control the circulation
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