Just when you think you have all the rules and regulations for your industry under control, another one pops up – and along with it – a looming deadline. Such is the case right now for the Life Sciences industry.

According to the U.S. Food and Drug Administration (FDA), companies filing electronic submissions must use the new electronic common technical document (eCTD) format as of Jan. 1, 2008. The eCTD message specification was developed by the M2 Expert Working Group of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) to be a common format for company-to-regulatory agency transfer of information prepared in accordance with the ICH CTD standard. The objective of eCTD is to harmonize both the content and the way it is delivered for the new drug approval process.

eCTD promises to help companies improve the submissions process, shorten time-to-market and minimize costs. In the past, companies would take their submission documents, print several copies, bind them and ship them to regulatory agencies such as the FDA. With the eCTD format, they’ll only need to submit the piece that has changed from the previous application to the revised application. This saves regulators time since they’ll only need to review the piece that has changed; and saves the company time and money, while potentially shortening the time for approval.

Unfortunately, as noted in a press release issued today by Open Text, many life sciences companies aren’t prepared for the FDA deadline. In order to comply with the eCTD submission requirements, pharmaceutical and life sciences organizations will need to find the necessary software support tools to be able to support the lifecycle of every submission component to help them manage the complex process of assembling, approving, releasing and archiving new drug and medical device applications.

To learn more about how companies can get ready for the eCTD, you can listen to a podcast I recorded with Harv Martens who has served for over 12 years on the ICH M2 Expert Working Group. In the podcast, we discuss the eCTD format, its impact on the life sciences industry, and what companies can do to comply with the FDA’s requirements. You can also tune into a Webinar recorded recently by Steven Pogrebivsky, president of Vital Path, an Open Text strategic partner in Life Sciences. Steven discusses the technology and regulatory challenges for electronic submissions, the benefits of the eCTD standard, and the product history of the Livelink ECM – Collaborative Submissions offering. Steve also presents a brief case study about Jazz Pharmaceuticals, who has successfully completed its pilot submission to the FDA using Open Text’s Collaborative Submissions module.