Analysis of the Medicinal Products for Human Use Authorised in the Russian Federation

Abstract

The available range of medicinal products is growing every year.The aim of the study was to analyse the range of medicines authorised in the Russian Federation.Materials and methods: the analysis covered the data presented in the State Register of Medicines (as of June 2021) and the current regulations specifying the range of medicines.Results: this article presents the results of analysis of medicines authorised in the Russian Federation, in terms of the following parameters: international non-proprietary names, trade names, groups according to the Anatomical Therapeutic Chemical Classification System, dosage forms, routes of administration, primary and secondary packaging, storage conditions, and shelf life. The analysis demonstrated that there are over 19 thousand medicines authorised in the Russian Federation, most of which are produced in Russia. The largest groups of medicines are antimicrobial products for systemic use, medicines for the treatment of nervous system and cardiovascular system disorders. The most common dosage form is tablets, and the most common primary packaging is vials. The most frequent storage temperature requirements are 15–25 and 2–8 °C. About half of all medicines have the shelf life of 3 years.Conclusions: the data presented in this article can be used for unification of approaches to maintaining the State Register of Medicines, elaboration of reference books, and will be useful for medicine developers and manufacturers when planning and preparing regulatory submissions.

Keywords

• range of medicines
• state register of medicines
• international non-proprietary name
• trade name
• dosage form
• primary packaging
• secondary packaging
• storage conditions
• shelf life