Global process for generic drug approval

Abstract

Drug approval standards in the United States are considered by many to be the most demanding in the world. Developing a new drug requires great amount of research work in discovery, development, preclinical research, clinical research. Reviewers in regulatory agencies throughout the world bear the responsibility of evaluating whether the research data support the safety, effectiveness and quality control of a new drug product to serve the public health. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. This work focuses on drug approval process in different countries like USA, Europe and India.