The Russian pharmaceutical market is expected to grow and attract foreign investors. Nevertheless, the frequent changes in regulatory legislation make the process of marketing authorization in Russia much more challenging than in Europe. In the present review, an insight into the practical issues caused by the implementation of the new marketing authorization law from 2010 until now is provided. The outcome of the new law application is contrary to the old one from 1998, which was amended once in 2000. To date, it has already been revised 19 times. The reasons for the frequent amendments as well as future perspectives are provided.

According to the Treaty on the Eurasian Economic Union, a common pharmaceutical market was supposed to become operational on January 1, 2016. Nevertheless, the responsible parties did not meet the deadline. Although a majority of the draft guidelines regulating this process were already known in 2014 and 2015, the anticipated process itself caused anxiety among representatives of the foreign pharma industry, who tried to prepare for coming challenges. Among other possible issues, the ambiguity of transitional periods and a lack of approved legislation were noted. Now only a few months remain until the end of 2016, but the market is still not functional. Furthermore, key documents relevant to the market still require approval by the Eurasian Economic Commission, and some of them even require discussion by representatives of member states. The present review provides readers with basic knowledge about regulatory procedures within the EAEU and the document approval process. It analyzes essential legislative acts and consequences for the pharma industry to take into account, including marketing authorization pathways, specific dossier requirements, and dates of their implementation. At the same time, reasons for the delay in the market's opening and future perspectives are discussed.

A serotonin catabolite, serotonin O-sulphate (5-HT-SO 4 ), is hypothesised to accentuate the intensity of serotonin metabolism in the central nervous system (CNS). We hypothesised that serotonin O-sulphate could be quantiied in human plasma using modern liquid chromatography-mass spectrometry. To test our hypothesis, we performed a critical literature review and a three-stage trial. First, a suitable liquid chromatography-mass spectrometry (LC-MS/MS) method for detection of 5-HT-SO 4 in human plasma samples was developed. Second, a pilot phase involving four healthy volunteers was executed. Finally, nine healthy volunteers were selected for the main study, where a basal plasma level of 5-HT-SO 4 was measured before and after serotonergic stimulation of the central nervous system. One h after stimulation, six study subjects showed a decrease in 5-HT-SO 4 levels, while three subjects showed an increase. This was the irst study in which naturally occurring 5-HT-SO 4 was detected by liquid chromatography-mass spectrometry (LC-MS/MS) in the samples of human plasma obtained from healthy volunteers. The method developed was speciic to the measurement of 5-HT-SO 4 and opens up new possibilities to evaluate minor pathways or serotonin metabolism by minimally invasive methods.

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