The Pharmaceutical Inspectorate of the Pharmacy Committee of the Ministry of Health of the Republic of Kazakhstan issued a certificate of compliance with the Good Clinical Practice to two clinical sites of RSE on REM “Karaganda State Medical University” (KarSMU) of the Ministry of Health of the Republic of Kazakhstan. This includes the Medical Center of KarSMU and Dental Clinic of KarSMU.
The standard of Good Clinical Practice (GCP) was approved by Annex 2 to the Order of the Minister of Health and Social Development of the Republic of Kazakhstan No. 392 of May 27, 2015. GCP standard includes the basic requirements for the clinical trials of medicinal products (Phases I-IV) and bioequivalence studies, clinical studies of medical devices and medical equipment. This is an international ethical and scientific standard for the quality of planning and conducting clinical trials of medicinal products involving human subjects, as well as documenting and presenting their results. The compliance with GCP ensures that the rights, safety and well-being of the trial participants are protected, and that the data obtained during clinical trials are reliable.