To assess the regulatory impact, an assessment was made of the results of a survey of 38 industry representatives and an analysis of 164 administrative decisions made as a result of an audit of the pharmacovigilance system, inspection and examination. It was found that in the first 9 months of 2018, the greatest difficulties arose with the preparation of periodic reports on the safety of medicinal products (PSR) by the DRU. Half of the interviewed DRUs (19 respondents) noted the presence of negative expert opinions on the submitted PHB, of which more than half (12 respondents) were domestic drug manufacturers.

The results of the analysis of administrative decisions of the regulator indicate the predominant role of proactive sectoral sources – almost all decisions were prepared on the basis of letters from applicants and the Federal State Budgetary Institution Scientific Center for Expertise of Medicinal Products of the Ministry of Health of the Russian Federation (FSBI NCESMP of the Ministry of Health of Russia) A survey of drug developers showed that individual organizations do not comply with the regulatory requirements for the submission of annual reports on the safety of the drug being developed, despite the results of the audit of the pharmacovigilance system, inspection and examination. This applies exclusively to the conduct of short-term clinical trials, for example, when assessing bioequivalence. There were no other problems with the preparation and submission of the necessary reporting by the drug developers.

The analysis of information sources for reporting showed that an important source of information for assessing the benefit and risk ratio in PHB is publications in the specialized media on the side effects of drugs and on administrative decisions of foreign and international regulatory and scientific organizations in terms of drug safety. To assess the quality of this information, a survey was conducted of the authors of 4 medical journals specializing in drug safety issues. The results of the survey showed a high level of understanding by the authors of medical journals of the required minimum amount of information sufficient for the high-quality operation of the pharmacovigilance system. Another important source of information for the DRU is the spontaneous reporting system. These messages are sent to the Pharmacovigilance database of Roszdravnadzor by various categories of respondents (clinical pharmacologists, representatives of pharmaceutical companies, representatives of regional departments of Roszdravnadzor, etc.).

Traditionally, the best quality information in spontaneous messages comes from specialized specialists – clinical pharmacologists and pharmacists of the Regional Centers for Monitoring Drug Safety (RCMBS). The results of a survey of RCMBS employees conducted from July 19 to September 21, 2018 showed that 25 out of 61 RCMBCs listed on the Roszdravnadzor website had their email addresses changed, many centers no longer exist, 3 centers responded to calls to them within 3 months or more. The share of spontaneous messages from RCMBLS is negligible. It can be concluded that the RCMBLS system in Russia is now virtually destroyed. The results of the audit of the pharmacovigilance system, inspection and examination confirm this. At the same time, the proactive work of the centers in certain regions of Russia continues to be carried out at a very high quality level, which makes it possible to rely on them when working with signals for drug safety.

*YU. V. Olefir1, B. K. Romanov1, R. N. Alyautdin1, V. K. Lepakhin, A. E. Krasheninnikov2, E. V. Shubnikova, Federal State Budgetary Institution Scientific Center for Expertise of Medicinal Products of the Ministry of Health of the Russian Federation , Petrovsky Boulevard, 8, bldg. 2, Moscow, 127051, Russian Federation. Autonomous non-profit organization “National Scientific Center for Pharmacovigilance”, Bolshoy Boulevard, 42, building 1, territory of the Skolkovo Innovation Center, Moscow, 143026, Russian Federation

* Safety and risk of pharmacotherapy. 2018.6 (4) .pdf