Abstract

FILING REQUIREMENTS FOR INVESTIGATIONAL NEW DRUG APPLICATION IN UNITED STATES AND CLINICAL TRAIL AUTHORIZATION IN EUROPE

*M. Ghazala Firdous, M. V. Nagabhushanam, G. Ramakrishna

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Abstract

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 drug approval process and filing requirements for Investigational New Drug Application (IND) in United States and Clinical Trail Authorization in Europe.

Keywords: Investigational New Drug Application (IND), MAA, USFDA, Drug approval, Clinical trial Authorization.