Challenges Faced During eCTD and CTD Filling Procedures for USFDA and Canada

摘要

Electronic Common Technical Document (eCTD) is a topic of increasing interest in the pharmaceutical Industry as it become compulsory for filing procedures. 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.Quality, Safety and Efficacy information is assembled in a common format?through CTD?.The CTD is maintained by the?International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use?(ICH). Electronic common technical document is an interface used by applicants of marketing authorisation for medical products to submit regulatory affairs document to the agency concerned. The purpose of this article is to present a concise overview of challenges faced during eCTD & CTD submissions in United States and Canada. A regulatory process, by which a person/organization/ sponsor/innovator gets authorization to launch a drug in the market, is known as registration process. The registration process will be done by submitting technical information to the authority.