Medicines

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"; (41 page(s), in Ukrainian)

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.