Bioequivalence study of generic medicines registered in the Medicines registration of Mongolia

Abstract

Background: The basis of this study is to analyse whether medicines are registered in Mongolia’s medicines registration based on their efÏcacy and further improve the medicines registration. Aim: Studying the registration of generic medicines in Mongolia’s medicines registration based on bioequivalence study results. Materials and Methods: The document analyses were carried out in the dossiers in the Medicine and Medical Devices Regulatory Authority archives. Study data were collected from 105 generic medicines dossiers registered in 2020 and 2021 using a survey card with 34 questions. The descriptive statistics were performed using the SPSS-26.0 statistical program to calculate the frequency and percentage of qualitative variables. The correlation between the factors was calculated by Pearson’s correlation. A statistically significant difference was considered in the case of p<0.05. Results: Of the 105 medicines studied, bioequivalence studies have been done on 42 (40%) medicines and 63 (60%) not. 61.9% of the studied medicines were tablets, and 89.5% were prescription medicines. Among the studied medicines, 21.6% (24) were produced in the United Kingdom of Great Britain and Northern Ireland, 12.6% (14) in the Republic of Korea, and 10% (12) in the Republic of India. According to the ATS code category, among the medicines and bioequivalence studies studied, medicines used for cardiovascular system disorders have the largest share. Regarding bioequivalence studies, 78.6% were performed in vivo, 2.4% were conducted in vitro, and 19% combined in vitro and in vivo methods. In vivo comparative dissolution studies were performed, while in vivo pharmacokinetic studies were performed the most (91%). Conclusions: 1. Bioequivalence studies have been conducted for 40% of the studied medicines, which indicates the need to improve the registration system of generic medicines based on their bioequivalence. 2. Bioequivalence studies have been conducted in vivo for 91% of the studied medicines.