Abstract
The processes of planning, performing, documenting, and follow-up of pharmacovigilance system inspections are regulated by the Good Pharmacovigilance Practices (GVP) and local regulations. These inspection processes apply mainly to marketing authorisation holders, developers of medicinal products for human use, and their authorised legal representatives, but they are presented from the perspective of regulatory authorities. Currently, there are no recommendations for pharmaceutical companies on how to prepare for a pharmacovigilance system inspection. The aim of the study was to develop recommendations on how pharmaceutical companies should prepare for a pharmacovigilance system inspection. The analysis of risks associated with scheduled and unscheduled inspections of pharmaceutical companies’ pharmacovigilance systems was performed with due consideration of the number of foreign marketing authorisations and the number of medicinal products under development according to the national registers of medicinal products and medical devices of the countries of the Eurasian Economic Union (EAEU), the Commonwealth of Independent States, and some European countries as of 30 June 2021. Some differences were identified in the work of Russian and foreign pharmacovigilance inspectorates, which are partially due to different numbers of EAEU-authorised medicinal products in the national markets. Based on the results obtained as well as personal experience as a pharmacovigilance officer in preparation of and participation in pharmacovigilance inspections of Russian companies by foreign regulators, implementation of corrective and preventive actions, the author of the paper has developed preliminary recommendations on how to prepare a EAEU pharmaceutical company’s pharmacovigilance system for an inspection. Effective management of pharmaceutical companies’ pharmacovigilance systems would contribute to the provision of the population with high-quality and safe medicines.
Highlights
The processes of planning, performing, documenting, and follow-up of pharmacovigilance system inspections are regulated by the Good Pharmacovigilance Practices (GVP) and local regulations
The analysis of risks associated with scheduled and unscheduled inspections of pharmaceutical companies’ pharmacovigilance systems was performed with due consideration of the number of foreign marketing authorisations and the number of medicinal products under development according to the national registers of medicinal products and medical devices of the countries of the Eurasian Economic Union (EAEU), the Commonwealth of Independent States, and some European countries as of 30 June 2021
Some differences were identified in the work of Russian and foreign pharmacovigilance inspectorates, which are partially due to different numbers of EAEU-authorised medicinal products in the national markets
Summary
В настоящее время отсутствуют рекомендации для фармацевтических организаций по подготовке к инспекции системы фармаконадзора. Цель работы: разработка рекомендаций по подготовке фармацевтической организации к инспекции системы фармаконадзора. Анализ рисков плановых и внеплановых инспекций систем фармаконадзора для фармацевтических организаций проведен с учетом данных о количестве зарубежных регистрационных удостоверений и разрабатываемых лекарственных препаратов в государственных реестрах лекарственных средств и медицинских изделий государств — членов Евразийского экономического союза (ЕАЭС), Содружества Независимых Государств и ряда европейских стран по состоянию на 30.06.2021. А также личного опыта выполнения функций уполномоченного лица по фармаконадзору, полученного при подготовке и прохождении инспекций зарубежными регуляторными органами систем фармаконадзора российских фармацевтических организаций и выполнении планов корректирующих и предупреждающих действий, автором статьи разработаны пилотные рекомендации по подготовке системы фармаконадзора фармацевтической организации государства — члена ЕАЭС к прохождению инспекции. Ключевые слова: фармаконадзор; инспекция; система фармаконадзора; надлежащая практика фармаконадзора; GVP; уполномоченное лицо по фармаконадзору; корректирующие и предупреждающие действия
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