The Modern Concepts of Pharmaceutical Development in the Context of the Transition to a Uniform Regulation of Medicinal Products Circulation

Abstract

Introduction. At the stage of transition from national to a uniform of circulation of pharmaceutical products regulation at the Eurasian Economic Union (EAEU) framework, harmonization of requirements for the development of medicines determines the need of use modern approaches, including the use of new methods and tools, thus to assure EAEU and other integration associations markets entry for effective and safe medicinal products. The new medicinal products development model, described in the ICH guidelines (The International Conference of Harmonization), involves a science-based approach to developing, using appropriate tools, such as defining a target product profile, establishing of critical quality indicators, risk assessment, establishment of design space, development of control strategy, drug lifecycle management and continuous improvement of existing processes. These approaches and techniques are not a part of the traditional paradigm of pharmaceutical development; although they are poorly understood and expensive, they are ensure the market entry of effective products with the desired quality parameters.Aim. Main purposes of this work are to compare two concepts of pharmaceutical developmentof medicinal products: traditional and improved, and to consider the necessity of new model usingin generic products development.Materials and methods. Research materials of this study were available literature sources, regulatory documents and guidelines regarding pharmaceutical products development, registration dossier documents, reports of regulatory authorities, pharmaceutical development reports. The achieving of study purposes was carried out on the basis of scientific research methods in the framework of comparative and logical analysis, and through the analysis and interpretation of the obtained data regarding pharmaceutical development of medicinal products.Results and discussion. On the basis of the data provided, author assess that modern concept it is a new, improved tool for development of medicinal products with specified quality parameters.Conclusion. The modern paradigm requires new expensive methods, stuff special knowledge and skills, investment and time, but it is effectively oriented on development of effective and safe medicinal products.

Keywords

• ich (theinternational conferenceof harmonization)
• quality by design
• traditional development
• improved approach
• risk assessment