Global Regulatory Harmonization and its Impact on the Biotech Industry's Commercial Success

Abstract

By creating cross-national indexes using data from the World Health Organization, this research aims to map the current situation of pharmaceutical control in the developing world. Surprisingly little is known about how national norms for pharmaceutical product control and market entry have evolved, despite the fact that medication ownership laws have been established and put into effect internationally. For measuring the research used SPSS software and generate result because the research based on primary data. This study develops novel pharmaceutical regulatory indicators using item response theory. We discover that emerging nations and regulatory infrastructure exhibit notable resistance to the application of international pharmaceutical standards for quality standards. In many underdeveloped nations, human potential is still constrained. The most notable difference is across states. It doesn't seem that nations who have taken the lead in creating international standards have encouraged their neighbors to create regional norms. Lastly, global standard-setters like the US or EU seem to have remarkably little impact on standard establishing across our study, which is in contradiction to conventional views of the dissemination of international standards. Overall result found that direct and significant link in between global regulatory harmonization with biotech industry’s commercial success. Our research offers a novel empirical technique for examining drug regulatory systems in developing nations and has consequences for how technical assistance is framed for public health efforts that aim to build local public institutions in medicine.