Compliance with GCP
Order of the Ministry of Healthcare of the Russian Federation No 200н of 01.04.2016 “On approval of Good Clinical Practice” was published on August, 23. It is of note, that Good Clinical Practice (GCP) is an international ethical and scientific standard of planning and conduct of studies in humans and documentation and presentation of results of such studies. These rules comply with principles of Helsinki Declaration of the World Medical Association (WMA) and support the reliability of clinical study data.
According to the document published, clinical trials (CT) of drugs are based on approval issued by the Russian Ministry of Health according to results of expert evaluation of documents for obtaining approval for CTs and ethical expertise. Requirements to ensure adequate quality of clinical trials of drugs, where particular attention is paid to organization, planning, the order of conduct and quality control of drugs, as well as documentation of results and archiving. Compliance with these GCP rules guarantees security and protection of study subjects.
A similar order by the Ministry of Healthcare of the Russian Federation of 01.04.2016 No 199н “On approval of Good Laboratory Practice rules” was registered with the Russian Ministry of Justice on August 15 cy.