Trends in the use of digital technologies and the development of IT-infrastructure for collecting spontaneous messages in the international pharmacovigilance system.

<jats:p>The international pharmacovigilance system accumulates a huge amount of valuable data. The speed and quality of processing such a volume of data to identify security signals directly depends on the level of digitalization both within national regulatory agencies and between them at the international level. Purpose: analysis of the IT infrastructure of the international pharmacovigilance system at different levels and trends in the use of digital technologies by regulatory authorities in various countries to increase the level of reportability and ensure timely exchange and processing of spontaneous messages. Materials and methods. Information has been searched in scientific literature publications and on the websites of regulatory agencies in the healthcare sector over the past 10 years. Results. Regulatory agencies carry out various activities to involve medical professionals and patients themselves in reporting, including training, information campaigns on social media, etc. Findings. Digitalization can help optimize pharmacovigilance processes at every stage: from the collection of data from patients/medical professionals directly or indirectly through pharmaceutical companies by regulatory agencies to the transmission and accumulation of data at the level of national regulatory agencies and international pharmacovigilance associations.</jats:p>