The Ministry of Health has regulated restrictions on the involvement and approval of clinical centers to participate in trials
On December 4, 2023, the Orders of the Ministry of Health of Ukraine No. 1745 and No. 1803 came into force, which abolished the obligation for healthcare facilities to provide a copy of the accreditation certificate for approval of clinical trial sites.
The EBA Clinical Trials Subcommittee has been working on the implementation of the relevant changes for a long time. Even before the full-scale invasion, the EBA appealed to the State Expert Center and the Ministry of Health with specific proposals to regulate the rule on the mandatory provision of accreditation certificates to bring it in line with the current requirements for the activities of healthcare facilities. As noted earlier, this provision, given the resumption of accreditation during martial law, has significantly affected the ability to submit and numerous refusals to approve clinical centers to participate in clinical trials, the number of which has significantly decreased during the war.
The EBA experts expect that the new changes will provide more opportunities for sponsors to select and engage clinical centers, both in trials already underway in Ukraine and in new projects, and will have a positive impact on the resumption of clinical trials in Ukraine.
We continue to work to improve the conditions for the resumption of clinical trials in Ukraine to accelerate the launch of innovative drugs in the world and to realize the opportunity for a significant number of seriously ill patients to receive modern examination, high-quality medical supervision and innovative treatment!