The article presents the results of the Scientific Centre for Expert Evaluation of Medicinal Products», Ministry of Health of Russia of the analysis and generalization of materials on the safety of clinical trials of medicines for medical use (including international multi-center clinical trials), permits for which were issued by the Ministry of Health of Russia. Study materials consist of 38273 submissions of developers of medicines, containing information about 62462 the occurrence of serious adverse events and serious adverse reactions to new drugs, and safety update reports from 1 July 2012 to 31 December 2016. The results of the analysis and generalization of obtained with the use of modern methods of investigation allowed the authors to establish the existence of quantitative and qualitative problems with material of safety clinical studies in 2012-2013. It is shown that already in 2013 the complex was developed and implemented measures helped to solve the identified problems: to increase by 22 times the number of clinical trial materials received from the Russian clinical centers and eliminate problems with the quality of the submissions, which is currently equally acceptable for all developers and organizations conducting clinical research. Recommendations for effective analysis and synthesis of the material safety clinical studies of medicinal products by the regulatory authorities, allowing to quickly make evidence-based decisions in relation to the preparation of recommendations for adoption of administrative decisions in the field of pharmacovigilance and clinical research.

Recently were appeared a fundamentally new insulin-independent approach to the treatment of type 2 diabetes - reduce blood glucose levels by inhibiting proteins co-transporters SGLT2 (sodium glucose transporter) in the proximal tubules of the kidneys, which are responsible for the reabsorption of glucose. Inhibitors SGLT2 co-transporters is effective either as monotherapy or in combination with other antidiabetic drugs. Thus, according to the results of randomized controlled trials, therapy with this class of drugs was well tolerated. The incidence of hypoglycemia was not statistically different from the incidence of hypoglycemia in the placebo group. On the background of therapy was observed a stable decrease in body weight in patients with type 2 diabetes. Therapy with all drugs of a class of SGLT2 inhibitors was accompanied by a decrease in blood pressure and body weight. This class of drugs could potentially play an important role in the early stages of development of diabetic nephropathy, with potential nephrorotective effect, working on the level of reduction intraglomerular pressure of a single nephron. Insulin-independent mechanism of action and low risk of hypoglycaemia makes the SGLT2 inhibitors effective and safe addition to existing methods of control glycemia in patients with type 2 diabetes.

New rules of good laboratory practice in the Russian Federation and the Eurasian Economic Union were adopted in 2016. The rules of good laboratory practice of the Eurasian Economic Union in the field of drugs is a document that will allow for a coordinated policy in the field of pre-clinical studies and to establish common principles and rules for the evaluation of medicinal products in the Member States of the Union with a view to forming a common medical devices market circulation. Creating uniform rules and approaches to the drugs market regulation based on international experience will increase the safety of drugs available on the market and their accessibility to the population of states - members of the EAEU.

We have prepared this review of the domestic and foreign scientific literature to characterize the different modern approaches to collecting of ADR information. Advent of new technologies in mobile devices and software applications is leading to facilitate information gathering. The importance of medical literature, social media and patient-generated data for pharmacovigilance were highlighted.