Aim. In order to determine the role of the biopharmaceutical classification system in the development of new drugs, the concept of bioavailability and bioequivalence has been investigated. Methods and results. Theoretically analysis of application of BCS in pharmaceutical development of solid dosage forms and systems analysis of research, relating to BCS has been studied. Article shows the analysis of the scientific researches of BSС and original sources application in the scientific bases of world level of SciTech development, a comparative analysis of freeing and absorption operating substances’ models, introduction of generic pharmaceutical preparations based on EMA, FDA, USP, WHO regulator documents. Conclusion. Biopharmaceutical classification system is a powerful factor in the development of new and effective generic drugs.