COMPARATIVE STUDY OF DOSSIER REGISTRATION PROCESS OF MULTI SOURCE HIGHLY VARIABLE DRUG PRODUCTS IN MAJOR COUNTRIES

In this paper we did individually study about the rule & regulations which are followed for drug approval process in USA & Europe & also we did individually study for the specific requirement of data in CTD, Paper documents for the marketing authorization of pharmaceutical products. Quality must ensure consistency of safety and efficacy during the shelf life of all batches produced. This paper summarizes here for the process of drug discovery procedure in brief & in co- ordination with the different regulatory authorities with Europe & USA and in last we did the comparative study. This comparative study of dossier compilation given a brief idea about the difference in regulatory requirements for drug approval process among USA & EU.

Keywords:  Dossier Registration Process, Multi Source Highly Variable Drugs, India, USA & Europe.