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Abstract

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*

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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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