REMEDIUM

The article presents a review of recent changes in the pharmacovigilance legislation, an analysis of drug safety monitoring activities of the Federal Service for Healthcare Supervision, a review of the current activities on improving pharmacovigilance, and outlines its development prospects.

EAEU countries to Russia shows a rather positive picture over the past three years. The rouble volume of products imported into our country shows double-digit growth rates, while the growth rates of monetary volumes noticeably outpace physical indicators. Changes in the range of products supplied substantially contributed to this growth. On the one hand, the products range is replenished with products of the upper price segment; on the other hand, supplies of individual low-cost MPs are reduced.

In recent years, the number of people suffering from sleep disorders has been steadily increasing in many countries around the world. This problem not only causes great discomfort and has a devastating impact on human health, but also has a negative impact on the socio-economic aspect of people's lives [1]. In this regard, the phar-macotherapy of sleep disorders is one of the topical issues of modern medicine.

In this paper, an overview of the decision-making rules and two one-sided tests procedure when assessing bioequivalence is provided. This includes a discussion of how the type I error is controlled, i.e. the way how the patient risks arising from the inherent uncertainty of statistical inferences are handled. Additionally, certain weaknesses of the current approach for the bioequivalence assessment are discussed.

Today in Russia, a new paradigm in building a healthcare system is being created - a value-oriented approach to treating each patient - with the aim of achieving high quality medical care in conditions of limited funding of healthcare system. An effective system of drug provision of patients forms the basis for the quality of medical services. The article presents a review of the medicine assistance schemes at the federal level. The data have been acquired from marketing agencies, as well as reports from the executive authorities of the Russian Federation for 2014-2017. Against the background of the positive dynamics of GDP in 2017 (+ 1.5% compared 2016), the amount of funding for the «Healthcare» expenditure section decreased by 13%. In recent years, the centralized expensive drug procurement system has been noted to be formed in the field of medicine assistance schemes. In the period from 2014 to 2017, the budget allocation for the provision of essential drugs (ED) saw a 12.5% increase. At the same time, the share of people who receive free drugs is only 21.6%, the rest of the patients prefer a cash payment. The high-priced nosologies program (about 50%) holds the leading place in terms of financial investments. In Russia, the drug supply system is built on the basis of optimization of resources, so it seems promising to find successful models of interaction between the state and the population at different levels in the segment of medicine assistance schemes.

Performance analysis of industry enterprises is conducted using the national statistics reports: Form No. P-1, term (monthly), Form No. P-2 Information on Investments in Non-Financial Assets (quarterly), Form No. P-3 Information on Company Financial Status (monthly).

The monthly review provides an analysis of court practice pertaining to the production and circulation of medical products to help industry specialists avoid mistakes in solving similar problems.

В начале прошлого года в России вступил в силу закон о телемедицине, предусматривающий оказание медицинской помощи дистанционно и открывающий новые возможности в сфере здравоохранения. Произошедшие за это время изменения и наметившиеся тренды обсудили эксперты, собравшиеся в марте на конференции «Телемедицина-2019. Вызовы и перспективы», организованной издательским домом «Коммерсантъ».