Indian Journal of Science and Technology

Abstract

Objectives: The articles analysis the role of convergence and harmonization of pharmaceutical regulation, as a basic component, ensuring pharmaceutical security and guarantying the realization of the right to health. Method: To achieve the main aim of the study national laws and documents of international organizations have been analyzed to identify main steps of human security concept formation and the role of access to healthcare in its realization. According to existing socioeconomic trends, main threats and challenges of pharmaceutical sector were identified showing the role of harmonization and convergence processes in its protection and realization of the right to health. Findings: An analysis of the processes taking place in different regions of the world, demonstrated the positive impact of regional integration to improve the health management system and the formation of common rules, regulating the drug market. Integration processes take into account regional specificities, providing point impact on the existing threats and challenges in the pharmaceutical sector, which allows neutralize differences in the capabilities of States to ensure the quality control of medicinal products within the same region. Focus on the convergence and harmonization of the legal framework will improve the drug regulatory system on a global level and ensure the quality of products used by patients, it is necessary to strengthen and provide numerous benefits for both regulators and the pharmaceutical industry and have a positive impact on the protection of public health. Improvements: The study result identifies main areas of harmonization and convergence of pharmaceutical regulations, which can be applied during regulation formation of any regional integrative organizations.
Keywords: Harmonization, Pharmaceutical Security, Regulation, Right to Health