Regulatory Aspects of Registration of Medicinal Products and Biologically Active Supplements

The pharmaceutical market has demonstrated significant growth rates for decades, one of the factors of which is the multiple increase in the range of biologically active additives. At the same time, segmentation of the pharmaceutical market into drugs and biologically active additives presupposes the presence of clear, unambiguous criteria that exist at the stages of their development, registration, production, promotion, and appointment. However, at present, the regulatory framework lacks parameters for criteria-based assessment from the standpoint of qualitative and quantitative composition. The aim of the study was to prove the conventionality of registration formats and to substantiate the criteria of certainty for biologically active additives and over-the-counter drugs. The material for the study was drugs and biologically active additives with a similar composition. The comparison method established that the quantitative content of biologically active components in the specified groups either corresponds to or exceeds that in biologically active additives. The obtained results not only indicate the blurring of boundaries between over-the-counter (and in some cases, prescription) drugs and dietary supplements, their conventionality, but also compromise such segmentation. This situation deserves close attention from the standpoint of both the rational use of dietary supplements and Pharmacovigilance. The proposed criteria assessment basically takes into account the intermediate position of dietary supplements between food products and drugs, given that they, like drugs, can also act as xenobiotics in the case of increased sensitivity of the body to their components, in violation of the regimen, or in excess of recommended doses. Possible criteria are: sources of origin of active substances, purpose, comparative quantitative composition in the presence of analogues, nature of side effects, which for medicinal products should not be limited to individual intolerance.