eCTD Spurs Communication Amongst Regulators

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When the ICH first met in 1990, the group of men and women could only dream of the ways in which their work would influence the future of regulatory authorities. One of the greatest accomplishments of the ICH is the Common Technical Document (CTD) which provides a common organization and structure for the information that drug companies submit. As the CTD evolved into its electronic counterpart, the eCTD, the ways in which drug regulatory authorities reviewed applications continued to progress. Today, regulators have acquired enough experience to develop best practices, and have dramatically increased the efficiency of the drug review process.

One lesser known aspect of this efficiency gain is that drug authorities often discuss applications and their review practices. For a number of years, the US FDA and EMA have shared confidential information about drug application reviews. These discussions often involve specific applications that are seeking approval in both regions. Because a common format is shared, sponsors are able to provide the information to multiple agencies simultaneously. Furthermore, since the applications are formatted in the same way, the regulators are able communicate their common concerns very effectively as the submissions are evaluated.

The ability of submissions to be received in eCTD format has allowed for greater efficiencies. Besides the obvious fact that electronic submissions can be delivered faster and more information can be stored in a smaller area, the eCTD format has led to repeatable best practices. The development of reviewer templates and tools for each discipline is made easier by having a common electronic format. Many of these tools and practices can be and are shared with other regulatory authorities resulting in harmonized good practices. The end result is the creation of a consistent approach to evaluating drug submissions and reaching conclusions in a systematic way.


Author: Rahul Mistry

Rahul Mistry is a veteran of the software industry. Mr. Mistry has two decades experience working in the technology product and services field. He was instrumental in the development of the eCTD REVIEW™ and VALIDATE™ software now used exclusively by the U.S. Food & Drug Administration to assess the technical integrity of each drug application the FDA receives.

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