Abstract

US IND AND EU-IMPD APPLICATION FILING REQUIREMENTS OF MAJOR COUNTRIES

K. Anitha*, M. V. Nagabhushanam and G. Ramakrishna

ABSTRACT

To demonstrate how the requirements and guidelines can be applied are used as references to file investigational new drug application. To develop and design the regulatory filing strategies for US investigational new drug and European investigational medicinal product dossier. To understand General investigational plans how to approach the regulatory agencies. To reduce the regulatory burden on industries while filing for new drug application. To understand the comparative regulatory strategies for US regulatory body and Europe regulatory agency. To support by filing to get approval of the sponsor’s wishing to conduct clinical studies with an investigational drug. To understand the safety studies to clear overall risk and benefit assessment.

Keywords: US IND, EU IMPD, Guidelines, Regulatory Requirements.