Information about the new rules and the outcome of the revision of the four restrictive lists of medicaments are submitted. Lists of vital and essential medicines, «preferential» list of drugs prescribed by a decision of medical commissions, the list of expensive drugs and the list of drugs constituting minimum pharmaceutical assortment are important documents for the pharmaceutical industry and for society as a whole, since the prices of drugs included in these lists are regulated by goverment. The problems of restrictive lists preparation are indicated. The recommendations for further improvement of the system of preparation of restrictive lists of medicaments are given.

Systematic evaluation of management principles by signals on medicinal drugs safety is submitted. The sources of signals, the approaches to the detection signal processing and detection, validation, analysis and prioritization, signal assessment are considered. A review of the individual security reports is demonstrated. A statistical analysis of large databases and processes of their regulation was shown. Practical recommendations for the identification of signals in national and international databases are given.

The risk management system includes the process of determining the probability of occurrence of undesirable effects of pharmacotherapy, identifying the extent and magnitude of the risk analysis and the choice of risk management strategy, the selection of necessary for this risk management techniques and strategies of ways to reduce it. Thus, the risk management system is a modern and efficient pharmacovigilance tools aimed to improve the effectiveness and safety of pharmacotherapy.

With the aim to harmonize the legislation between the Eurasian Economic Union countries and the European Union in the field of medicines circulation and taking into account the requirements of the European Union and the Organization for Economic Cooperation and Development (OECD) in 2015 were developed the Rules of Good Laboratory Practice EAEC. The article presents the results of a comparative analysis of good laboratory practice. Order of the Ministry of Health of the Russian Federation on the Rules of good laboratory practice will allow to provide the most objective study of the safety of new drugs at the preclinical stage and to identify and prevent using of unsafe drugs. Ultimately, it will protect the interests of patients and the healthcare system as a whole.

Milk Thistle (Silybum marianum) is a widely used herbal remedy, which has a relatively low risk of drug interactions. However, there is evidence in the literature about the possible impact of thistle drugs on activity of microsomal enzymes and p-glycoprotein. Contradictory data depends on differences in study protocols. The existence in the database case reports of drug interactions with milk thistle suggests a possible clinically significant effect on the activity of cytochrome P450 enzymes.