03 April 2012

RAPS: Mastering the eCTD Format Critical for Regulatory Submissions Pros - By Zachary Brousseau

The electronic Common Technical Document (eCTD) is designed to make regulatory submissions easier and more efficient—for drugmakers and for regulators. It provides a common global standard for companies to electronically submit the quality, safety and efficacy information required for approval of a new drug to regulatory agencies in the US, EU, Canada and Japan.

In the US, the reauthorization and update of the Prescription Drug User Fee Act (PDUFA), which expires later this year—the updated bill is dubbed PDUFA V as it is to be the fifth iteration of the user fee law—is set to elevate the eCTD format to a requirement for all New Drug Applications (NDAs) and Biologics License Application (BLAs) beginning in 2015, and for Investigational New Drug Applications (INDs) beginning in 2016. It has been required for Centralised Procedure applications to the European Medicines Agency (EMA) since 2010. Use of the format is also strongly encouraged in Canada, Japan and emerging markets around the globe. Therefore, anyone who works on drug regulatory submissions needs to understand the format well.

Although it is likely to become an FDA requirement only this year, the eCTD is not new. The eCTD’s paper-based predecessor, the Common Technical Document (CTD), was developed by the International Conference on Harmonisation (ICH) in 2000, and the eCTD evolved in 2003.

The eCTD benefits regulators by allowing them to use computer-based tools such as searching, copying and pasting text, making the review process more efficient. Regulators can complete reviews online, allowing for more timely reviews to meet legislative timelines, which ultimately benefits sponsors, as well. For sponsors, eCTD submissions can be less expensive to produce and ship, provided they have properly refined business processes to accommodate the change from the paper-based format to an all-electronic one.

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