The Ectd Advantage - White Paper
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 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.
References: • The ISI 2008 Emerging Biopharmaceutical Pulse Survey; Image Solutions, Inc. • Preparing Compliant eCTDs; Regulatory Affairs Professionals Society (RAPS) • Fastest Drug Developers Consistently Outperform Their Peers, Generating Substantially Higher Revenue and Cost Savings ; Tufts Center for the Study of Drug Development; September/October 2006 Tufts CSDD Impact Report • DIA Webinar: The New Look at eCTD Lifecycle Management: How Mapping from NDA to IND can Streamline Submission Lifecycle Chores; June 4, 2009; Michelle Perez, ISI, Connie Robinson-Kuiperi, FDA-CDER