WTO notification · TBT
UkraineProposed measure, may since have been adopted
Official title
Draft Order of the Ministry of Health of Ukraine 'On Approval of Amendments to the Procedure for Conducting Clinical Trials of Medicines and the Examination of Clinical Trial Materials'
Ukraine notified this proposed TBT measure to the WTO on 5 January 2026. The comment period closed on 6 March 2026.
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Source: WTO ePing (opens in a new tab). Summaries by Expodite, which is independent of the WTO.
Published here:
Medicines
The comment period closed on 6 March 2026. You can still raise concerns about the measure with your country's WTO TBT enquiry point, quoting the document symbol G/TBT/N/UKR/367; it can take them up with Ukraine.
Find your country's enquiry point on WTO ePing (opens in a new tab)The draft Order has been developed to enhance the system for organizing and conducting of clinical trials of medicines in Ukraine in accordance with Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, and in line with ICH-GCP Guidelines. The draft Order proposes to update requirements for clinical trial documentation, introduce new terms (including auxiliary and advanced therapy medicines, early termination of a clinical trial, start of a clinical trial, end of a clinical trial, and batch certification of the investigational medicines), establish labeling requirements, define the concept of co-sponsorship, and allow the conduct of low-intervention clinical trials.
Expodite writes its summary from the official record. The notification and the documents it notifies are on the WTO's own websites.
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