Regulatory policy for quality control of biopharmaceutical products in Ukraine

Abstract

The aim of this study is to conduct a comprehensive analysis of the current regulatory policy for ensuring the quality of biopharmaceutical products in Ukraine, to evaluate its effectiveness, and to identify promising areas for improvement, particularly in the context of harmonization with international regulatory guidelines. A set of general scientific and specialized methods was employed, including analysis, synthesis, generalization, a systems approach, and comparative legal analysis. Current approaches to regulatory policy in the field of quality control of biopharmaceutical products, specifically biotechnological medicinal products in Ukraine, have been systematized. A generalized quality control framework covering various stages of the product lifecycle has been proposed. It was established that the quality control system for biopharmaceutical products is a multi-vector structure integrating state supervision with international standards. Control encompasses the entire product lifecycle, from verifying the genetic stability of cell banks and monitoring critical fermentation parameters to in-depth analysis of post-translational modifications of the API and biosimilarity assessment based on the principle of analytical and functional similarity. A key role in ensuring the safety and quality of biopharmaceutical products is played by the restoration of routine state control (effective from 2025) and the operation of a network of accredited laboratories performing arbitration analysis and validation of specific biological activity indicators. The scientific novelty lies in the systematization and structural organization of regulatory approaches to the quality control of biotechnological medicinal products in Ukraine and in the identification of their key components. The practical significance of the study lies in the systematization of regulatory and analytical requirements for the quality control of biopharmaceutical products, which can be used by pharmaceutical companies to enhance internal quality assurance systems and streamline state registration procedures.