Current regulatory requirements and regulation on submission of ANDA in India comparison with Singapore

Developing a new drug requires great quantity of research work in chemistry, manufacturing, controls, preclinical science and clinical trials. Drug reviewers in regulatory agencies around the world bear the liability of evaluate whether the research data support the safety, efficacy 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 article focuses on history, regulatory policy and organization, and related issues with respect to different countries like, India and Singapore.