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Abstract

REASONABLE STUDY ON CTD AND eCTD FOR USFDA AND HEALTH CANADA FILING PROCEDURE

K. Ashok Kumar*, D. Nagarjuna Reddy, M. V. Nagabhushanam, Brahmaiah Bonthagarala and G. Ramakrishna

ABSTRACT

The aim of work is to know the Active Substance Master Filing process in US and CANADA & their comparison. To know the DMF involvement in e-CTD and also the drug substance filing process comparison between Food Drug Administration (USA) and Health Canada (CANADA) and DMF involvement in the modules of eCTD and it’s filling. The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies. Reformatting for multiple submissions is substantially limited. The CTD has improved the regulatory review processes and enabled implementation of good review practices. The eCTD has increased efficiency for reviewers and improved submission times. This article will provide you with an in-depth review of the content and format requirements of the CTD/eCTD. Hands-on activities will include organizing specific study reports and other documents into the CTD, using tools for the project management of the CTD preparation, and pre-publishing an eCTD.

Keywords: Master Filing process, Drug Master Filling (DMF), eCTD, CTD, Food Drug Administration (USA) and Health Canada (CANADA).


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