COMPARISON OF REGULATORY REQUIREMENTS FOR GENERIC DRUGS DOSSIER IN UNITED STATES AND EUROPE

ABSTRACT Common technical document (CTD) provides a standardized structure for regulatory submissions that is acceptable in all ICH countries. Although the CTD makes multinational filing easier, there are significant differences in the dossier submission requirements in these countries. This study put forth the differences in registration requirements for generics in United States. Generic drug in US they are approved under the abbreviated new drug application. Bio availability and bio equivalence study data is critical in the generic drugs approval process. decentralized body which is responsible for safety regulation of the food and drug products in Europe, and the manufactured is obligated to establish bioequivalence of their drug to the ‘European reference product’. KEYWORDS: CTD, generic drugs, bioequivalence, MAA