<\/p>\n
On 9 July, the European Business Association’s Clinical Trials Subcommittee held a meeting to review its activities during the first half of 2026, discuss preparations for the launch of the Ukrainian Pharmaceutical Agency (UPA), analyse the key provisions of the new Clinical Trials Procedure, and define the next steps towards aligning Ukraine’s clinical research framework with European regulatory approaches.<\/p>\n
During the meeting, Subcommittee members noted the progress made in implementing the priorities set for 2026. In particular, experts actively contributed to the development of secondary legislation required for the implementation of the Law of Ukraine “On Medicinal Products”, preparing and submitting proposals on the new Clinical Trials Procedure, licensing requirements, the Regulation on the Ukrainian Pharmaceutical Agency, requirements for the import of investigational medicinal products, and other implementing regulations. Ongoing cooperation with the Ministry of Health of Ukraine and the State Expert Centre remained an important area of work aimed at improving the regulatory environment for clinical research.<\/p>\n
Particular attention was paid to the current state of clinical trials in Ukraine. According to the monitoring results for the first half of 2026, the sector has demonstrated positive momentum and a significant increase in activity compared with the same periods in previous years. The number of newly approved clinical trials increased by 1.8 to 3.8 times, while the number of approved clinical trial sites grew by 2.6 to 4.5 times. There was also a notable increase in the number of additional clinical sites joining ongoing studies. These results indicate the gradual restoration of Ukraine’s attractiveness as a destination for international clinical research, even under wartime conditions.<\/p>\n
One of the central topics of the meeting was preparations for the launch of the Ukrainian Pharmaceutical Agency, which is expected to begin operations on 1 January 2027. Participants discussed the current level of readiness for the transition to the new regulatory model, as well as the potential risks associated with the establishment of the new authority. Key challenges identified included the timely adoption of secondary legislation, the readiness of IT systems, ensuring the continuity of application review processes, and the smooth transfer of responsibilities between institutions. Following the discussion, Subcommittee members reaffirmed the importance of maintaining active dialogue with the Ministry of Health, the State Expert Centre, and the future regulator to minimise risks and ensure the stable functioning of the clinical research sector during the transition period.<\/p>\n
Participants also conducted a detailed review of the most sensitive provisions of MoH Order No. 184, which introduced the new Clinical Trials Procedure. Industry representatives highlighted the need for further refinement of several provisions before the regulation enters into practical application. Key issues include alignment with EU Regulation No. 536\/2014, the digitalisation of procedures, improvements to the mechanism for substantial amendments, the role of ethics committees, and shorter timelines for regulatory decision-making. The Subcommittee agreed to prepare a consolidated set of business recommendations to improve the document and continue its professional dialogue with the regulator.<\/p>\n
A separate part of the meeting focused on preparations for introducing the Single Decision mechanism as one of the elements of Ukraine’s future integration into the EU Clinical Trials Regulation (EU CTR) and Clinical Trials Information System (CTIS). Participants agreed that preparatory work on the concept should begin now, as implementing such a model will require both legislative changes and a transformation of the way ethics committees operate. As a result of the discussion, the Subcommittee supported the establishment of a working group to develop the concept and roadmap for implementing the Single Decision mechanism in Ukraine. The Subcommittee’s priorities for the second half of 2026 include supporting the industry’s preparations for the launch of the Ukrainian Pharmaceutical Agency, developing amendments to MoH Order No. 184, and shaping Ukraine’s approach to future integration into the EU CTR\/CTIS framework.<\/p>\n
The Association thanks the members of the Clinical Trials Subcommittee for their active participation, high level of expertise, and constructive dialogue. Through the joint efforts of the business community, public authorities, and industry experts, Ukraine continues to build a modern and predictable regulatory environment that will support the further development of clinical research in the country.<\/p>\n
<\/p>","protected":false},"excerpt":{"rendered":"
On 9 July, the European Business Association’s Clinical Trials Subcommittee held a meeting to review its activities during the first half of 2026, discuss preparations for the launch of the Ukrainian Pharmaceutical Agency (UPA), analyse the key provisions of the new Clinical Trials Procedure, and define the next steps towards aligning Ukraine’s clinical research framework […]<\/p>\n","protected":false},"author":33544,"featured_media":757098,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false},"categories":[4,5,22],"tags":[],"yoast_head":"\n