Regulatory Frameworks and Guidelines: Understanding the Landscape for Pharmaceutical Companies

Abstract

Propose: The regulatory regulations of different nations globally differ from one another. As a result, it is difficult for the corporations to create a single medication that can be concurrently filed for approval in every country. The various requirements for registration for generic medicine in the US were presented by the present research. In the United States, approved under the abbreviated new drug application are generic medications. Exclusivity rights, which prevent generic businesses from launching a product right away after patent expiration, are used to prolong a product's patent duration after it has expired. The United States (US) generic marketplace was the study's main objective.