Pre-clinical trial of a medical drug is performed with the help of scientific evaluation methods in order to prove safety, quality and efficacy of the medicinal drug (Art. 11 of Federal law №61-FZ dated April, 2010 « On Medicine Circulation»). Pre-clinical trial of the medical drug is performed according to the rules of Good Laboratory Practice approved by the authorized federal government agency.
Clinical study – is a study involving a human as the test subject for discovery or confirmation of clinical and/or pharmacological effects of the studied products and/or for detection of adverse drug reaction and/or for analyzing their absorption, distribution, metabolism in order to evaluate their safety and/or efficacy.
According to Part 1. art. 13 of Federal Law of the Russian Federation № 61-FZ , dated April 12, 2010 «On Medicine Circulation» drug substances are put into civil commerce on the territory of the Russian Federation if they are licensed by an appropriate authorized federal executive agency.
