The Ectd Advantage - White Paper

Topics: Drug development, New Drug Application, Food and Drug Administration Pages: 5 (1506 words) Published: December 14, 2012
August 20, 2009
The eCTD Advantage
By Michelle Perez

Life science companies in today’s shrinking economy are looking for ways to maintain growth in the face of imminent patent expiration, growing generic competition, and escalating drug development cost. One way an increasing number of sponsors are cutting expenses and time to market is by transitioning to the electronic Common Technical Document (eCTD) format right from the Investigational New Drug (IND) application. The eCTD has a number of features that can speed up submission publishing and review times, including cross-application linking capabilities that allow sponsors to submit a document just once and refer to it as many times as necessary in subsequent submissions and applications.

Focusing on the IND as a product application starting point (and the typical beginning of the clinical trial period), this article will address eCTD structure and functionality and outline the possibilities and pitfalls of building a submission strategy that takes advantage of the cross-application linking feature to achieve the following: • Cut publishing and review times in the NDA; • Improve submission and lifecycle management functions across all product applications.

The eCTD: ICH Format Designed for Efficiency
The Common Technical Document (CTD) was developed by the International Conference on Harmonization (ICH) and is fast becoming the preferred or required submission format by regulators in the world’s major marketplaces and beyond. Since July 2003, the CTD has been mandated for marketing and post-marketing applications in Europe, Japan, and Canada. The Food and Drug Administration (FDA) has required eCTD submissions since 2008, and the European Medicines Agency (EMEA) wants all Centralised Procedure applications in the eCTD format by the start of 2010. Although the industry has been bracing for change for some time now, many drug makers are making the transition to eCTD just ahead of regulatory deadlines. The result is that often many of the eCTD technical advantages are lost due to the lack of planning and understanding, as companies struggling with unfamiliar formats and processes fail to effectively plan for the product lifespan.

The Basics
The CTD is a submission format, so it does not change the content requirements for the IND, New Drug Application (NDA), Marketing Authorization Application (MAA) or any other regulatory submission. It does, however, allow sponsors to more efficiently manage submission publishing, transmission and lifecycle chores, in part by organizing required information into smaller chunks or “granules” that are more easily assembled and managed over the application’s lifetime. These granules are placed into a rigid, well-defined folder structure that allows sponsors and regulators to take a more consistent and harmonized approach to submission building and review. The “e” in the eCTD denotes a change in transmission methods – the CTD is a paper submission that is hand-delivered, while the eCTD is an XML-based version that is submitted via electronic media or directly through secure regulator gateways. Among the advantages of electronic transmission, management and storage, the eCTD allows submission builders to map to documents within and across all submissions and applications. This feature can save on time and cost, but only if properly set up and managed from the start of the product IND application.

IND: Planning is Key
According to a survey conducted in 2008 by ISI, a longtime global regulatory submission consulting firm, INDs are the most anticipated submission for 2009, with two-thirds of the companies surveyed in the Phase I stage of development saying they plan to file an IND this year. A majority of the 216 survey respondents (63%) were emerging companies with fewer than 250 employees.

However, in order for sponsors to get the most out of their IND eCTD submissions, there needs to be a good understanding of how the...
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