إجراء مقترح من أوكرانيا: مستلزمات المختبرات الطبية

The draft Order provides for amendments to the Procedure for Conducting Clinical Studies (Trials) of Medicinal Products, approved by Order of the Ministry of Health of Ukraine No. 184 of 16 February 2026 'Certain Issues on the Procedure for Conducting Clinical Studies (Trials) of Medicinal Products'. The amendments aim to eliminate regulatory barriers to conducting clinical trials in Ukraine and update the applicable procedural requirements in accordance the provisions of the Law of Ukraine No. 2469-IX 'On Medicines'. The key amendments include: clarifying requirements for Phase I clinical trials and bioequivalence studies conducted on an outpatient basis, including intensive care unit (ICU) support, and updating quality assurance and compliance requirements for bioanalytical laboratories; allowing multilingual labelling, provided that the text is identical in all languages, and revising the documentation requirements for clinical trial applications; introducing an accelerated review procedure, including preliminary review within three business days, at the applicant’s request, and specifying the applicable review timelines, conditions for conditional decisions and preparatory steps before a trial may commence; establishing clear timelines, ranging from 10 to 60 days, and streamlining procedures for reviewing substantial modifications to ongoing clinical trials.