MARKETING AUTHORIZATION PROCESS OF NEW DRUG SUBSTANCES IN U.S.A AND EUROPE

A regulatory process, by which a person/organization/sponsor/innovator gets authorization to launch a drug in the market, is known as drug approval process. In general, a drug approval process comprises of various stages: application to conduct clinical trials, conducting clinical trials, application to marketing authorization of drug and post-marketing studies. 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 the drug approval process in India. Developing a new drug requires great amount of research work in chemistry, manufacturing, controls, preclinical science and clinical trials. Drug reviewers in regulatory agencies around 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 article focuses on history, regulatory policy and administration, and related issues with respect to different countries like U.S.A. , Europe ,China, Australia and India. Keywords: USFDA, EMA, TGA, Clinical trials, Approval stage