Analysis of international experience in creating reference standards databases

Abstract

The article analyses international experience in creating analytical databases with information on reference standards. The authors examined and compared publicly available databases, i.e. reference standards catalogues posted on the official websites of the European Directorate for the Quality of Medicines and Healthcare, the United States Pharmacopoeia, the British Pharmacopoeia, the National Institute for Biological Standards and Control. The article summarises features of each of the databases and compares the number of reference standard characteristics that are reflected in the databases. Based on the results of the analysis the authors assessed the existing international approaches to the creation of reference standards databases and determined the main information units to be taken into account while creating a reference standards database. The development of such a database will help improve and coordinate the collection and systematization of data on reference standards and promote the effectiveness of the Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation.