Abstract

REGULATORY GUIDELINES FOR GENERIC PRODUCTS REGISTRATION IN MIDDLE EAST COUNTRIES

V. Triveni*, M. V. Nagabhushanam, G. Ramakrishna, Y. Ratna Sindhu and Brahmaiah Bonthagarala

ABSTRACT

The pharmaceutical manufacturer needs to incorporate the technical requirements and all other documents of new pharmaceuticals to market their products in other countries. In this presentation it is individually discussed about the rules and regulations which are followed for drug approval process in Middle East Countries. Any product should reach the criteria of the individual country guidelines. This study mainly discusses “Regulatory Guidelines for Generic Products Registration in Middle East countries” By following the guidance and regulations of FDA, ICH and WHO, filing process of pharmaceuticals in Middle east countries will become very easy and accurate. Compilation in eCTD module will be helpful in reviewing of dossier in a very short time. In this competitive world of pharma generics, an attempt is made to highlight the difference between the two major countries registration requirements through CTD format.

Keywords: Generic Products, Middle East countries.