eCTD HOW TO DO DOCUMENT

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eCTD is a topic of increasing interest in the pharmaceutical environment. In the past, the main
focus for regulatory authorities was eCTD submissions sent via MAAs. As a result, introduction of
eCTD by API manufacturers was slow with limited eCTD guidance for API dossiers.
In recent times, however, the number of eCTD submissions for API manufacturers has increased
(the FDA have reported an increase of eCTD submissions year on year) and guidance documents
have been published that make it possible to create and maintain API dossiers using eCTD. API
manufacturers are also beginning to understand the benefits from the adoption of eCTD.
This document will focus on eCTD only as it is considered the upcoming standard for electronic
submissions. There are other options for electronic submissions such as NeeS (Non eCTD
electronic Submission) in Europe or a single pdf-file. However, these submission types are not
ICH-standard so their uses are limited when dealing with customers in different regions.
It must be noted, however, that when it comes to eCTD submission, there continues to be
differences among different countries and even ICH regions. For example, the FDA began
accepting eCTD submissions in 2003; Japan began accepting in 2004, yet the EU Heads of
Medicines Agencies committed themselves, in 2005, to be ready for eCTD submissions by 2010.
The approach of the different health authorities also continues to be different. For example,
Japan has accepted eCTD since 2004 but eCTD submissions of API dossiers are not possible; in
Europe, some agencies continue to require paper submissions for specific sections.
Outside the ICH region, countries are continuing to adopt the eCTD initiative and there is potential
for eCTD to become the standard for non-ICH countries.

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Manostaxx – Industrial Management Consulting

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