In accordance with paragraph 5.1.4.1 of the Resolution of the Government of the Russian Federation dated June 30, 2004 № 323 “On Approval of Provision on Federal Service for Surveillance over Public Health”, the department for supervision over clinical trials organizes and conducts inspections of the subjects of circulation of medicines for compliance with the requirements for pre-clinical testing and clinical trials set by the Federal Law “On circulation of Medicines” and other regulatory legal acts of the Russian Federation accepted in accordance with the Law.
In accordance with paragraph 40 of Art.4 of the Federal Law dated April 12, 2010 № 61-FZ “On Circulation of Medicines” a pre-clinical testing of a medicine is defined as biological, microbiological, immunological, toxicological, pharmacological, physical, chemical and other trials of a medicine by means of scientific methods of assessment for the purpose of obtaining evidence of safety, proper quality and efficacy of a medicine.
In accordance with paragraph 41 of Art.4 of the Federal Law dated April 12, 2010 № 61-FZ “On Circulation of Medicines”, a clinical trial of a medicineis defined as studies of diagnostic, therapeutic, prophylactic and pharmacological properties of a medicine in the process of use thereof by a human being or an animal, including, but not limited to the processes of absorption, allocation, modification and excretion, by means of scientific methods of assessment for the purpose of obtaining evidence of safety, proper quality and efficacy of the medicine, data on adverse reactions to the use of the medicine by a human being or an animal, and the effect of interaction thereof with other medicines and (or) food substances, or animal food substances.
