إجراء مقترح من أوكرانيا: مستلزمات المختبرات الطبية

Ukraine notifies Order of the Ministry of Health of Ukraine No. 184 of 16 February 2026, 'Certain Issues Concerning the Procedure for Conducting Clinical Studies (Trials) of Medicinal Products'. The Order aims to eliminate regulatory barriers to conducting clinical trials in Ukraine and update the applicable procedural requirements in line with the provisions of Law of Ukraine No. 2469-IX of 28 July 2022 'On Medicines'. In particular, the Order approves the Procedure for Conducting Clinical Studies (Trials) of Medicinal Products and the Requirements for the Form and Content of Informed Consent for Participation in Clinical Studies (Trials). The Procedure for Conducting Clinical Studies (Trials) of Medicinal Products establishes the main requirements for conducting clinical trials of medicinal products in Ukraine, including advanced therapy medicinal products, combined advanced therapy medicinal products, bioavailability and bioequivalence studies, and international multicentre clinical trials, involving patients or healthy volunteers. The Order was developed taking into account the provisions of Directive 2001/83/EC, Regulation (EU) No 536/2014, Regulation (EC) No 726/2004 and Commission Directive 2005/28/EC, including its provisions on the authorisation of the manufacture or import of investigational medicinal products, with the aim of regulating the conduct of clinical trials of medicinal products and the assessment of clinical trial documentation.