Abstract

GLOBAL REGULATORY CHALLENGES OF COMMON TECHNICAL DOCUMENT

Singh Satbir*, Kumar Pankaj and Rana Arpana

ABSTRACT

Developing an innovative drug product and submission of a new drug application is the ultimate goal of the every pharmaceutical company. Pharmaceutical company plans a strategy for registration of drug product in several countries in the form of a universally adopted common technical document format. The Common Technical Document (CTD) is a set of specification for application dossier for the registration of Medicines and designed to be used across Europe, Japan and the United States. It was developed by the European Medicines Agency (EMEA, Europe), the Food and Drug Administration (FDA, U.S.) and the Ministry of Health, Labour and Welfare (Japan). The CTD is maintained by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The CTD was designed to provide a common dossier filing format between U.S, Japan and European countries for the registration of new drug product. Differing in registration requirements across the world market are the challenges for the effective and successful submission of an application of a new drug product.

Keywords: CTD, FDA, ICH, EMEA, etc.