Ukraine authorizes clinical trials through a two-track model: the State Expert Center (SEC) of the Ministry of Health of Ukraine reviews the scientific and regulatory dossier, while a Local Ethics Committee (LEC) at the proposed trial site reviews the ethical and participant-protection dimensions independently, in parallel. There is no national or central ethics committee in Ukraine and no equivalent of a single national IRB — ethics review is conducted institution-by-institution, which makes the coordination between the SEC track and the LEC track the operational center of gravity for any sponsor planning a Ukrainian site.
What the State Expert Center Authorizes
The SEC is a state enterprise under the Ministry of Health of Ukraine that performs the scientific and regulatory expert evaluation of clinical trial applications, alongside its separate (and larger) role evaluating medicinal-product registration dossiers and overseeing post-marketing pharmacovigilance. For a clinical trial specifically, the SEC’s positive decision is the regulatory authorization that permits the trial to proceed at the sites and under the protocol reviewed — a trial cannot legally begin in Ukraine without it, and clinical research may only be conducted at sites the Ministry of Health has authorized on the basis of that positive SEC decision.
The base legal and procedural framework dates to Order of the Ministry of Health of Ukraine No. 690 (23 September 2009), which set out the original procedure for conducting clinical trials of medicinal products and the associated expert evaluation of trial materials. That framework was substantially amended by Order No. 190 (31 January 2023) and Order No. 1034 (7 June 2023), changes that industry sources describe as roughly halving the review timeline compared to the pre-2023 process and making the SEC’s review stages more transparent to sponsors. Because the current pathway sits on top of a 2009 order amended twice in 2023, sponsors researching Ukraine will encounter both older and newer timeline figures depending on when a given source was written — the same pattern seen in other jurisdictions where a base clinical-trials order has been reformed in stages (see CASRAI’s guide to Argentina’s ANMAT pathway, where the statutory day-count moved across three separate reforms).
The Parallel-Track Model: SEC and Local Ethics Committee
Ukraine’s defining structural feature, relative to many other national pathways, is that the regulatory submission to the SEC and the ethics submission to the site’s LEC can be filed simultaneously rather than sequentially. A sponsor does not need to wait for SEC clearance before submitting to the ethics committee, or vice versa — the two reviews proceed independently and in parallel, each reaching its own decision. This is a meaningfully different model from jurisdictions that require sequential regulatory-then-ethics (or ethics-then-regulatory) sign-off, and it is one of the practical reasons Ukraine has historically been attractive for multinational trial start-up timelines when both reviews go smoothly.
Because there is no central ethics committee, every LEC operates independently at its own institution, with its own composition, meeting cadence, and administrative practices. A multi-site Ukrainian trial therefore means coordinating with a separate LEC at every site, not a single national ethics decision that other sites can rely on — a materially different administrative burden than jurisdictions with a single national or regional ethics body. (Israel’s Helsinki Committee structure runs on a broadly comparable logic of parallel institutional review; see CASRAI’s guide to Israel’s Helsinki Committee pathway for a point of comparison.)
How Long Approval Actually Takes: Statutory Versus Practical Timelines
This is the figure sponsors most often need and the one where published sources genuinely disagree, so it’s worth being precise about what each number describes rather than citing a single day-count as settled fact.
- Statutory SEC timeline: 47 calendar days. Multiple current sources on Ukraine’s clinical trial pathway cite 47 calendar days as the statutory window for the SEC to issue its initial decision on a complete Clinical Trial Application, a figure consistent with the post-2023 reform (Orders 190/2023 and 1034/2023) that industry commentary describes as roughly halving the pre-2023 review period.
- Practical/typical timeline: closer to 90 calendar days. The same sources that cite the 47-day statutory figure separately note that sponsors and CROs report actual, practical timelines running closer to 90 calendar days once dossier-completeness back-and-forth, translation requirements, and administrative processing are factored in. Whether a given trial lands nearer the statutory floor or the practical estimate depends heavily on dossier quality at first submission and how quickly a sponsor responds to SEC observations.
- Statutory LEC timeline: 30 calendar days. Local Ethics Committee review runs on its own statutory clock, separate from the SEC’s, though in practice a given LEC’s actual meeting schedule and administrative capacity can affect how closely it tracks that figure.
Sponsors should treat 47 days as the regulatory floor written into current procedure and 90 days as a more conservative planning estimate for total elapsed time to SEC decision — not as two competing claims where one source is simply wrong. This gap between a statutory floor and a practical planning figure recurs across national pathways generally; CASRAI’s guides to Argentina and Colombia document the same pattern with their own respective statutory-versus-typical gaps.
The Application and Dossier Process
The SEC submission process runs in two stages. First, the sponsor notifies the SEC of a new submission; the corresponding application form is then forwarded within 3 calendar days of that notification. Second, the sponsor files the complete Clinical Trial Application dossier for substantive review. Both the SEC and the relevant LEC conduct a single review round as standard practice — each issues written observations only once rather than iterating through multiple rounds of comments, which is part of what keeps the overall process bounded.
If the SEC or LEC raises observations, the sponsor has defined windows to respond: 60 calendar days to respond to SEC comments and 30 calendar days to respond to LEC comments. An incomplete dossier must generally be supplemented within 30 days or the application may need to be resubmitted. Given Ukraine’s regulatory language is Ukrainian, dossier translation and locally compliant informed consent materials are a real project-planning input, not a formality — see CASRAI’s entry on translated informed consent materials for the general considerations that apply to any jurisdiction requiring local-language consent documentation.
Import Authorization for Investigational Products
Ukraine does not require a separate import or export permit for investigational medicinal products. Instead, the SEC’s positive study approval itself functions as the authorization to import IMPs, non-investigational products, and other study materials, provided that information was included in the original submission. Sponsors should still confirm current VAT treatment for imported trial materials with local counsel or a CRO, since VAT rates applied to clinical trial materials in Ukraine have differed depending on the material category.
Site Authorization and Trial Registration
A positive SEC decision is necessary but not sufficient on its own — clinical research in Ukraine may only be conducted at sites the Ministry of Health has specifically authorized, based on that SEC decision. All clinical trials must also be registered with the SEC as part of this process. In practice this means the SEC’s role extends beyond a single “approve or reject” gate: it underpins both the trial-level authorization and the site-level authorization that follows it.
Regulatory Continuity Since 2022
Ukraine’s clinical trials infrastructure, including SEC review and LEC operations, has continued functioning throughout the full-scale invasion that began in February 2022, and industry and regulatory commentary (including from the SEC itself, via forums such as DIA’s Global Forum) has specifically addressed how sponsors and sites can maintain trial continuity under wartime conditions. As of January 1, 2025, the SEC’s own reporting indicated 324 clinical trials underway in Ukraine, a scale sponsors evaluating the country as a trial site should weigh against the operational realities of running a multi-site study in an active conflict zone — site-level feasibility, participant safety planning, and business-continuity provisions warrant more detailed diligence than the regulatory pathway alone.
How Ukraine’s Pathway Compares to Other National Models
Ukraine’s parallel SEC/LEC submission model sits closer to jurisdictions like Israel, where institutional ethics review (via Helsinki Committees) and regulatory review can also move on independent tracks, than to jurisdictions that require sequential sign-off. It shares the “statutory floor versus practical planning figure” pattern seen in Turkey’s TITCK pathway and in Latin American frameworks such as Argentina’s ANMAT and Colombia’s INVIMA, where a single published day-count rarely tells the whole story and the underlying regulation has typically been reformed more than once. Across all of these pathways, trial conduct itself is still expected to follow ICH Good Clinical Practice principles (see also CASRAI’s guide to Good Clinical Practice and the current ICH E6(R3) revision), even where the national authorization pathway that gets a trial started differs substantially from one country to the next. For the broader landscape this guide sits within, see CASRAI’s clinical research pillar page.
Frequently Asked Questions
Is there a central ethics committee in Ukraine?
No. Ukraine has no national or central ethics committee equivalent to a single national IRB. Ethics review is conducted by an independent Local Ethics Committee (LEC) at each participating institution, which means a multi-site trial requires separate ethics submissions and decisions at every site.
Can SEC and ethics committee review happen at the same time in Ukraine?
Yes. Submission to the SEC and to the relevant Local Ethics Committee can be filed in parallel rather than sequentially, with each body reaching an independent decision on its own track.
How long does SEC approval take in Ukraine?
Sources differ on this. The statutory window most commonly cited under the current framework (as amended by 2023 orders) is 47 calendar days, while sponsors and CROs frequently report practical, real-world timelines closer to 90 calendar days once dossier back-and-forth and administrative processing are factored in. Treat 47 days as a regulatory floor and 90 days as a more conservative planning estimate.
Do sponsors need a separate import license for investigational products in Ukraine?
No separate import or export permit is generally required. The SEC’s positive study approval itself authorizes import of the investigational medicinal products, non-investigational products, and study materials specified in the original submission.
What happens if the SEC or LEC raises questions about a submission?
Both bodies typically issue written observations in a single review round. Sponsors then have defined response windows — 60 calendar days to respond to SEC comments and 30 calendar days to respond to LEC comments — before a final decision is issued.
