BRIEF REVIEW ON CTD AND e-CTD AS PER USFDA AND EMA
P. Ramya, S.V. Mounica, S.N. Swarropa and Dr. Daka Nagarjuna Reddy*
Abstract
The Common Technical Document (CTD) used to be designed to
supply a frequent layout between Europe, USA, and Japan for the
technical documentation covered in a software for the registration of a
human pharmaceutical product. “The widespread structure for
submitting submissions, modifications, supplements, and reports to the
Centre for Drug Evaluation and Research (CDER) and the Centre for
Biologics Evaluation and Research (CBER) of the FDA is recognised
as digital Common Technical Document (eCTD).
Keywords: Common technical document, Electronic technical document, ICH, FDA, ANDA.
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