The transition of the Russian Federation to the implementation of a risk-based approach to control and supervisory activities in the field of pharmacovigilance from January 1, 2018 increased the number and significance of documentary checks, audits, inspections, examinations of the pharmacovigilance system, including quantitative and qualitative assessment of reporting, and minimizing risks in this part has become relevant for all subjects of the drug safety system. Preparation of express reporting as a result of examinations of pharmacovigilance systems and periodic reporting on the safety of a medicinal product (drugs) is carried out on the basis of the Order of Roszdravnadzor dated February 15, 2017 No. 1071 “On approval of the Procedure for the implementation of pharmacovigilance” in the form and within the time frame specified in the Decision of the Council of the Eurasian Economic Commission of 03.11.2016 No. 87 “On Approval of the Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union” by drug developers (organizations in whose name a clinical trial permit was issued, or legal entities authorized by them) and holders of registration certificates (DRU) of all registered in the Russian Federation medicines (MP) for medical use.

Reporting forms are submitted by the DRU independently within the time frame specified by the rules, or as a result of an inspection of the pharmacovigilance system or an audit of the system. DRU and drug developers submit reporting forms in the recommended way – by sending them to the Federal Pharmacovigilance database of Roszdravnadzor (for DRU) or to the MKILS database (Monitoring of clinical trials of drugs) of Roszdravnadzor (for drug developers). If the cause of an adverse event in the course of a clinical trial was the use of a registered drug, express reporting of this event is sent by the drug developer to the Pharmacovigilance database of Roszdravnadzor.

An alternative way is to send reports to other databases, except for situations with express reporting to independent ethical committees on the safety of clinical trials of drugs being developed. Pharmacovigilance audit system, inspection, examination of marketing authorization holders are carried out in accordance with the schedule determined by the rules.

*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