The use of drugs (MP) in practical medicine is inextricably linked with the risk of adverse reactions (AD), which in many cases is caused by an insufficiently established level of drug safety. Studying and ensuring the safety of medicinal products at different stages of the life cycle is an important element of the pharmacovigilance system.

Formation of documents on pharmacovigilance, standard operating procedures (SOPs) for pharmacovigilance and transfer of master files to regulatory authorities are an integral part of the system.

The formation of the pharmacovigilance system dates back to 1848. Further, the world pharmacovigilance system has undergone several stages of development from the organization of local institutions to the formation in 1949 by the World Health Organization (WHO) of the world institute of pharmacovigilance in the form of the Council of International Organizations in the Field of Medical Sciences (Council for International Organizations of Medical Sciences (CIOMS).

The next stage of development was the integration of pharmacovigilance systems from different countries of the world, which was initiated in 1968 by the World Health Organization. The WHO Center for International Monitoring of Medicines, established in Uppsala (Sweden), has accumulated reports on ADRs reported by all countries participating in the program. Within the framework of the organized Center, the first international database of drug safety reports, VigiBase, was developed, which combined information on all registered cases of HP on drugs contained in local pharmacovigilance centers. A list of pharmacovigilance documents, pharmacovigilance standard operating procedures (SOPs) and the structure of the master file were determined.

Since its inception, all HP data has been transmitted and stored in VigiBase, mostly in paper form. The transition to the use of digital technologies in the system for collecting information about HP became possible in the 1990s. based on the model proposed by the Council of International Organizations of Medical Sciences (CIOMS) [22]. The harmonization of the form of electronic communication about HP took place thanks to the adoption in 1997 of the international standard for the transmission of information on drug safety E2B, developed by the International Conference on the Harmonization of Technical Requirements for Registration of Medicinal Products for Human Use (ICH). The standard defined pharmacovigilance documents, pharmacovigilance standard operating procedures (SOPs) and a master file to be submitted as part of the Submission of a Periodically Updated Drug Safety Report.

A.E. Krasheninnikov1, A.V. Matveev1,2, E.A. Egorova2

Bulletin of VolgGMU.pdf