Ukraine is moving toward EU-aligned regulation and one of the most impactful areas is clinical research.
1️⃣ Faster approval timelines for clinical trials
The law introduces differentiated timelines depending on trial type:
• up to 50 days for standard interventional trials
• 20 days for low-intervention trials
• 25 days for international multi-centre Phase II–III trials (subject to SRA/EU approvals)
2️⃣ Introduction of low-intervention clinical trials
A new legal category is defined with clear criteria:
• use of authorized medicinal products
• application aligned with SmPC or supported by scientific evidence
• minimal additional risk to patients
3️⃣ Stricter framework for pediatric trials
New requirements significantly reshape pediatric research:
• mandatory consent from minors + parents or legal representatives
• additional requirement: positive opinion of a pediatric committee
• for vulnerable children (orphans, deprived of parental care), trials now require:
Ethics committee decision, pediatric committee input
, and possible involvement of Ombudsman
.
Importantly: clinical trials involving minors cannot start until the pediatric committee is established.
4️⃣ Expanded rules for vulnerable populations
Special procedures will apply to:
• pregnant and breastfeeding women
• military personnel
• persons in detention
5️⃣ New operational & regulatory requirements
The law introduces several structural changes:
• creation of a State Register of clinical trials
• mandatory licensing for import of investigational products (from 2028)
• GMP inspections of investigational product manufacturing
6️⃣ Ethical safeguards & restrictions
Key patient protection measures include:
• mandatory informed consent after recovery for emergency patients
• prohibition of gene therapy trials affecting germline genetic identity
7️⃣ Reduced administrative burden (selectively)
Storage period for batch certificates reduced from 25 years to:
– ≥1 year after expiry or ≥5 years (whichever longer)
💡Ukraine is clearly aligning its clinical research framework with EU standards – but the transition will not be frictionless.
What to expect?
✔ Faster approvals
✔ More structured trial categories
✔ Stronger ethics & patient protection Increased compliance, licensing, and operational costs
.png)
.svg)
.svg)
.svg)
