New role of extemporaneous manufacturing in regulating drug products access onto the market

The aim of the work was to study legal aspects legislative regulation for manufacturing medicines in a pharmacy organization. Materials and methods. Databases ConsultantPlus, Cyberleninka, Food Drug Administration (FDA), European Medicines Agency (EMA), National Center Biotechnology Information (NCBI), PubMed, e-library, WIPO Lex were used as search sources. based on following keywords phrases: intellectual property, pharmacies+invention, patent, drugs, extemporal+production, orphan+diseases, well their Russian counterparts. 133 sources information, including scientific articles regulations, found out; 50 have been included this review. analysis information published from 2013 2023, determined by peculiarities legislation changes area. Results. article provided an overview modern, regulatory practice, pharmaceutical Federation, also analyzed benefits activity medical community, patients state. At same time, individualization drug treatment has made it possible out systemic solutions developing therapy methods special groups whom economic feasibility registration launching such drugs onto market brought into challenge. In addition, is accessible tool prescribed doctor not accordance with instructions use (off-label) or dosage forms/dosages that are market. Extemporaneous can be part process “repositioning” market, subject compliance requirements control safety. possibility pharmaceutic makes partially resolve issues related property. As result carried analysis, hypothesis confirmed: similar assessment both Russia abroad correspond practice resolving property relation organizations. Conclusion. renewal production will improve availability care population, taking account individual dosages forms various therapeutic areas, become repositioning clinical testing new molecules rare incurable diseases.