Abstract

COMPARITIVE STUDY OF DOSSIER SUBMISSION PROCESS FOR DRUG PRODUCT IN USA, EU & INDIAN REGULATORY

Swapna.G*, Bindhu Madhavi .Ch, Anusha.P , Rupa.T , Mohini.D , Venkkana.B,

Abstract

In this presentation we did individually study about the rule & regulations1 which are followed for drug approval 2process in USA, Europe & India. Data 3in the dossier4 gives the answer of following questions: What is the product? Is the quality 5presented acceptable on grounds of Safety 6and efficacy? Is the quality7 presented reproducible? How long can the quality be maintained8? Quality must ensure consistency of safety and efficacy during the shelf life9 of all batches Produced. And in last we did the comparative 10study. This comparative study of dossier compilation given a brief idea about the difference in regulatory requirements11 for drug approval process among USA, EU & India.

Keywords: USA, EU & India.