Health Care, Clinical Trials
Owing to effective collaboration with the State Expert Center of the Ministry of Health of Ukraine (SEC, MOH) the proposal of the EBA Clinical Trials Subcommittee regarding updating MOH Order 690 on clinical trials conducting procedure in accordance with international standards has been considered and adopted.
Starting from 2017, the EBA repeatedly brought the issue of clinical trials compliance with international standards to the attention of the state authorities, and highlighted the need to update domestic regulation. This need arose as Regulation (EU) No.536/2014 of the European Parliament and of the Council of 16 April 2014 has come into force.
The EBA expresses its gratitude to the State Expert Center for the support of our proposal and organization of the Working Group with Subcommittee representatives’ involvement. We hope that this initiative will serve as a next step forward to improve scientific and research industry conditions in Ukraine, which will increase access to high-quality and innovative treatments for patients.