Clinical Trials in Ukraine 2022–2025: Recovery Dynamics and Future Outlook
This publication draws on orders of the Ministry of Health of Ukraine regarding the conduct of clinical trials and the approval of substantial amendments (hereinafter, MoH Orders on CT/SA), published on the official MoH website [1], as well as open data from the information resource of the State Expert Center of the Ministry of Health of Ukraine (SEC MoH) [2].
The analysis covers MoH Orders on CT/SA from May 2022 through December 2025, inclusive.
Iryna Magdik
Executive Director of the EBA Clinical Trials Subcommittee
The years 2022–2025 became a period of both severe challenges and profound transformation for clinical trials in Ukraine. Despite the full scale war, the sector demonstrated remarkable resilience and a gradual recovery after an abrupt decline: the number of new clinical trial protocols and the network of clinical trial sites expanded several fold, and international sponsors have begun returning with new projects.
The expansion of trial site infrastructure, improvements in the regulatory environment, and uninterrupted functioning of the regulator ensured continuity and quality of clinical trial conduct. Against the backdrop of global shifts – digitalization, hybrid and decentralized models, and intensifying competition – Ukraine preserved key operational advantages. However, delays in harmonizing with the EU Clinical Trials Regulation (EU CTR) and integrating into CTIS pose significant risks to maintaining speed, securing investment, and sustaining participation in international research.
Four Years of Resilience: Recovery and Transformation Amid War
Over the past four years, clinical trials in Ukraine have traveled a difficult but illustrative path – from uncertainty during the first months of the full‑scale invasion to gradual recovery and the return of international sponsors with new protocols. An analysis of the Ministry of Health (MoH) orders approving clinical trials from May 2022 to December 2025 reveals a coherent and consistent picture of the sector’s transformation, where adaptability, quality, and strong engagement from clinical trial sites became decisive factors.
2022: Uncertainty and the Struggle for Treatment Continuity
During the first months of the full‑scale war, a significant number of ongoing international clinical trials halted patient enrollment; projects preparing to launch were frozen or cancelled; logistics chains were disrupted; and several clinical sites, especially those in frontline regions, lost the ability to continue operations. Efforts across the sector were concentrated on maintaining ongoing studies and securing uninterrupted access to treatment for enrolled patients.
2023–2025: Return of International Sponsors and Structured Recovery
Already since 2023, the number of new clinical trials began to grow, forming a positive trend that continued over the next two years. In 2025, the number of new clinical trial protocols approved by the MoH increased by 3.1 times compared with 2022 and by 2.4 times compared with 2023. This growth shows a steady and systemic pattern, signaling a gradual return of international companies.
Expansion of Clinical Trial Sites: Recovery of Infrastructure and the Role of Decentralization
Another notable trend of this period is the expansion of active clinical trial sites with new geographic distribution. The number of clinical trial sites (CT sites) approved for participation in new studies in 2025 grew 4.2 times compared with 2022 and 2.8 times compared with 2023. Overall, from 2022 to 2025, the MoH approved 947 CT sites across 199 clinical trials conducted by 86 sponsors.
This is a critical indicator, reflecting not only the return of sponsors but also the stability and operational capacity of Ukrainian clinical sites and their ability to maintain high‑quality standards aligned with GCP requirements. The expansion of sites also broadens patient access to innovative therapies across different regions – a particularly important humanitarian and healthcare advantage during wartime – while decentralization helps keep the clinical trial ecosystem functional and resilient.
Expansion of Ongoing Studies: Additional Sites as a Marker of Sponsor Confidence
Significant growth was also seen in the expansion of ongoing clinical trials. In 2024–2025, the number of additional CT sites approved for active protocols more than doubled compared with 2022–2023. In total, 545 additional CT siteswere approved within 131 ongoing studies run by 51 sponsors during 2022–2025.
This trend indicates strong trust in Ukrainian sites, demonstrating their ability to conduct clinical trials at a consistently high standard. It also reflects confidence in Ukraine’s overall stability as a clinical trial location: strong patient availability, positive site-sponsor cooperation, and predictable regulatory processes.
PTTA Programs: A New Tool for Ensuring Access to Innovative Therapies
Regulatory approval for PTTA (Post‑Trial Treatment Access) programs, designed to maintain access to investigational products for patients after completing a clinical trial, was introduced during the full‑scale war [3], [4]. Implementation was swift: since May 2023, the MoH approved 13 PTTA programs, ensuring continuity of therapy for more than 160 patientsacross multiple clinical sites.
Sponsors demonstrated a clear commitment to supporting access to innovative therapies for patients with severe conditions, particularly when no alternative treatments exist. This support is especially important during wartime, when providing access to advanced medications requires additional resources.
Regulatory Stability as the Foundation for Sustaining the Sector
The uninterrupted functioning of the MoH, the State Expert Center (SEC), and ethics committees became one of the decisive factors that kept the clinical trials sector from collapse. From the first day of the invasion, the MoH actively supported clinical trial operations and amended regulatory acts where necessary. The SEC continued reviewing clinical trial and substantial amendment submissions without interruption, provided guidance to investigators and sponsors, and resumed clinical trial inspections and audits just months after the invasion began. Ethics committees adapted rapidly to ensure continuous functioning.
Over four years, the SEC conducted more than 100 inspections/audits, while thousands of professionals underwent GCP training. This systematic regulatory support preserved quality standards, which remain the foundation of sponsor trust.
Factors Behind the Return of International Companies in 2024-2025
Multiple factors contributed to Ukraine’s renewed attractiveness:
- stable operation of the regulator,
- expansion of the CT sites network,
- consistently high quality of trial conduct,
- strong patient availability,
- streamlined regulatory procedures,
- introduction of PTTA programs.
In 2024–2025, Ukraine began receiving new protocols from leading global pharmaceutical companies, including Merck Sharp & Dohme, AstraZeneca, F. Hoffmann-La Roche, Sanofi-Aventis, Eli Lilly and Company, Bristol Myers Squibb. The number of sponsors approving new clinical trials in 2024–2025 increased 1.8 times compared with 2023.
Between 2022 and 2025, the MoH approved 199 new clinical trial protocols from 86 sponsors, including companies entering Ukraine for the first time amid wartime conditions. Some global companies not initiating new studies in Ukraine continued active ongoing clinical trials and started open‑label extension protocols, such as Janssen Pharmaceutica, Novartis Pharma, AbbVie, Pfizer, Bayer and others.
Therapeutic Areas: Trends of 2023-2025
Since 2023, there has been moderate growth in clinical trials across several key therapeutic areas: oncology, gastroenterology, psychiatry, neurology, rheumatology, and pulmonology.
Ukraine in the Global Clinical Trials Landscape: Competition, Digitalization, and Regulatory Change
To understand Ukraine’s position, global market trends must be considered. The global clinical trials industry is undergoing a rapid transformation: digitalization, application of AI tools, expansion of hybrid and decentralized trial models, increasing competition for innovative protocols, and a reduction in oncology study volumes [5], [6], [7], [8], [9], [10], [11], [12].
The European Union, after introducing the new EU CTR (Regulation No. 536/2014) and transitioning to CTIS, is experiencing a structurally complex period and a temporary loss of competitiveness. The share of EEA countries in innovative clinical trials decreased from approximately 22% in 2013 to about 12% in 2023. Against this backdrop, countries in Eastern Europe are actively competing for new protocols. Recognizing these challenges, the EU is working to restore competitiveness – primarily through the ACT EU (Accelerating Clinical Trials in the EU) initiative aimed at optimizing regulatory processes and accelerating trial start‑up [13].
Simultaneously, China and North America continue strengthening their positions, rapidly expanding infrastructure and operational capabilities.
In this environment, speed, transparency, and operational efficiency have become critical competitive factors.
Future Challenges and Opportunities: EU Integration and Regulatory Reform
Despite the war, Ukraine retains important competitive advantages: fast study start‑up timelines, effective patient recruitment, and high protocol compliance. However, to preserve and strengthen these advantages, Ukraine must:
- harmonize its regulatory framework with EU requirements without sacrificing operational efficiency,
- scale digital solutions (eConsent, ePRO, telemedicine, remote monitoring),
- develop and support a regional network of clinical trial sites.
A significant strategic challenge is the need for full integration with EU CTR, including full integration CTIS system. Delays in preparation carry the risk of losing competitiveness, as sponsors favor countries with unified regulatory processes and high operational predictability.
Another major transition lies ahead: the implementation of the new Law on Medicines and the establishment of a single regulatory authority – the Ukrainian Pharmaceutical Agency (UPA) – from January 1, 2027. This shift requires early preparation, including updated regulatory procedures, modernized IT infrastructure, comprehensive applicant guidance, pilot testing of new systems, clear review timelines (SLAs/KPIs), and strengthened staffing for the transition period.
A proactive approach will ensure procedural continuity and maintain Ukraine’s key strengths – speed, quality, and transparency.
Strategic Priorities for the Next Stage of Growth
The years 2022–2025 were not a period of decline for Ukraine, but rather one of systemic transformation. Ukraine not only preserved its status as a reliable clinical research location but also confirmed it under conditions that would have been critical for many other countries. The 2.4–2.8‑fold growth across key indicators demonstrates the maturity, resilience, and adaptability of Ukraine’s clinical trials ecosystem.
To return to pre‑war levels and surpass them, coordinated strategic action is required across all stakeholders – patients, investigators, clinical sites, sponsors, CROs, logistics providers – under strong leadership from the state.
The next stage must shift from recovery to growth. Ukraine should define and implement strategic priorities:
- Full integration into the EU regulatory environment (EU CTR/CTIS)
Harmonization and technical readiness to operate within CTIS are essential for competitiveness and participation in multinational trials. - Development of digital infrastructure and hybrid/decentralized clinical trial models
Digital tools (eConsent, ePRO, remote monitoring, telemedicine etc.) will expand patient access, accelerate recruitment, and align Ukraine with global best practices. - Expansion of regional clinical trial site networks
Strengthening and professionalizing regional CT sites will enhance resilience and improve patient access to innovative therapies. - Implementation of the single regulatory authority
Creating a unified regulator with clear processes, timelines, and digital systems will increase speed, predictability, and transparency.
Ukraine is well‑positioned not only to reclaim its place on the global clinical trials map but to secure a more prominent and strategically important role. The foundations for this advancement were laid through the outcomes and trends observed in 2022–2025.
Source: The Pharma Media
[3] https://zakon.rada.gov.ua/laws/show/2469-20#Text
[4] https://zakon.rada.gov.ua/laws/show/z1269-22#Text
[5] https://www.who.int/observatories/global-observatory-on-health-research-and-development
[7] Clinical trials regulations reform – Health Research Authority
[11] https://globalforum.diaglobal.org/issue/november-2024/emerging-regulatory-trends-in-asia-pacific/
[12] https://www.mfds.go.kr/eng/wpge/m_1176/de011009l001.do
[13] https://accelerating-clinical-trials.europa.eu/index_en
