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The Ministry of Justice of Ukraine registered Order No. 1525 of the Ministry of Health of Ukraine dated August 24. The Order approved the “Procedure for approval and implementation of the program of expanded access of patients to unregistered medicinal products and the program of early access of trial subjects (patients) to the medicinal product after the completion of the clinical trial”.<\/p>\n
This Order completes the implementation of the project of the EBA Clinical Trials Subcommittee, which lasted almost 2 years. The abovementioned Procedure has shaped the final legislative framework for the implementation in Ukraine of programs for expanded access and early access of patients to unregistered innovative medicines. According to the representatives of the Subcommittee, the implemented legislation not only complies with modern international and European practices but is also a crucial step to ensure the availability of innovative treatment for patients in Ukraine. It should be noted that only a few countries in the world currently have comprehensive legislative regulations for such programs.<\/p>\n
We hope that these progressive rules will give Ukrainian patients a new chance for life through access to treatment with innovative drugs and will contribute to the development of clinical trials in our country!<\/p>\n
Compassionate programs can already be officially approved and implemented! Wishing much success to those involved!<\/p>\n
We thank all representatives of the EBA Clinical Trials Subcommittee companies who took an active part in the Subcommittee’s project on legislative regulation of this issue in Ukraine. Our joint efforts with the people’s deputies of the Verkhovna Rada of Ukraine, and colleagues of the Ministry of Health of Ukraine made it possible to implement the expected regulatory rules for the official continuation of treatment of patients with experimental innovative drugs after the end of their participation in clinical trials.<\/p>\n