Life Sciences Industry Facing New Challenges with the FDA's Latest Electronic Submissions Requirements

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Companies filing electronic submissions must use new Electronic Common Technical Document (eCTD) format by Jan. 1, 2008. An integrated process for regulated content will help companies create, review, maintain and archive electronic submissions. Are companies ready?

In the past, companies would take their documents, print a multitude of copies, bind them and quite often put them on a truck and ship them to the FDA or the concerned regulating body

The life sciences industry has long faced the difficult challenge of regulatory submissions, managing large volumes of required documentation and different rules across geographies. The industry's adoption of a new document standard, called the electronic common technical document (eCTD), promises to help companies improve the submissions process, shorten time-to-market and minimize costs. But according to recent analysis by Open Text™ Corp. (NASDAQ: OTEX, TSX: OTC), a global leader in enterprise content management (ECM), while the eCTD format can more than live up to its billing, many companies are unprepared for the looming Jan. 1, 2008 U.S. Food and Drug Administration (FDA) deadline to comply with the standard.

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. It is accepted across the United States, Japan, the European Union and Canada. The CTD and related eCTD address the requirements throughout the lifecycle of the electronic submission. According to Harv Martens who has served for over 12 years on the ICH M2 Expert Working Group, the objective of the CTD/eCTD is to harmonize both the content and the way it is delivered for the new drug approval process.

"Pharmaceutical companies handle huge amounts of documentation for regulatory submissions. The information gathering process is very costly. If that information can't be used in more than one region because of separate guidelines, it causes delays and expense in the development of new drugs," said Martens. "The ICH and other regulatory authorities are working together to address the inconsistencies in the guidelines, the various regional requirements, and the implementation of the various software tools to ensure they comply with the standards." Martens and Therese Harris, Program Manager for Life Sciences at Open Text, released a podcast today where they discussed the eCTD format and its impact on the life sciences industry.

Preparing for the FDA's Deadline

Beginning January 1, 2008, the FDA will require that all electronic submissions to the Center for Drug Evaluation and Research (CDER) must use the eCTD format. Despite the benefits of a standardized framework, pharmaceutical and life sciences organizations are faced with challenges in finding the necessary software support tools that will enable them to comply with the eCTD submission requirements. What steps should an organization take to be ready for the eCTD?

According to Harris, as companies move to the eCTD format in key markets, they must create a single, unified environment that supports 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. But according to Open Text, many firms lack such an integrated platform. Although many of the pieces may exist, there are many areas where key functionality is contained in silos or some processes are still paper-based, causing companies to lose valuable time and face increase expense.

For the eCTD to be successful, companies must capture all documents, including responses to questions, variations/amendments and renewals in a consistent electronic format. The eCTD submission is composed of a backbone using XML, which supports the complete lifecycle of the submissions process. The backbone manages the metadata describing the submission and each document within the submission. For example, the metadata includes information about the kind of submission, the submitting and receiving organizations, and the manufacturer, and at the document level includes version information and descriptive information such as document title and its location in the CTD table of contents.

The backbone will also indicate if a particular file being submitted is new, if it is replacing or appending to a previously submitted file, or if a previously submitted file should be "deleted" (withdrawn from the review process). This will enable rolling submissions, allowing organizations to effectively submit their documents incrementally.

Companies can find significant benefits in using one, primary software product to manage the integrated regulatory content and submissions process. An enterprise content management system has the tools to support large collections of regulated content. Given the simplified, XML-based requirements of the eCTD, a range of collaborative process-support, tracking and reporting tools can be integrated with the content repository to manage the entire submission process, packaging and exporting the electronic documents that are stored in the repository.

"In the past, companies would take their documents, print a multitude of copies, bind them and quite often put them on a truck and ship them to the FDA or the concerned regulating body," said Open Text's Harris. "With the eCTD format, they'll only submit the piece that has changed from the previous application to the revised application. This process offers time savings and efficiencies at the FDA (or other regulator) since they will only need to review the piece that's changed and do not need to leaf through a document that could be up to a million pages in length. It is a huge value both at the company's end as well as at the regulator's end, and potentially shortens the time to approval."

Open Text's Livelink ECM - Collaborative Submissions supports the complete lifecycle of the submissions process, providing pharmaceutical companies with the tools to exchange information with government regulators, as well as manage and track changes to millions of pages of documents from multiple submissions. It combines a full document management feature set, rich metadata support, huge scalability, and a wide range of secure, collaborative business-process tools. Documents that will be used for submission are put through the regulated content process which requires electronic signature, audit and retention, or records management. The active integration between the Livelink ECM platform and the submissions tool continues to monitor the original document so if any changes are made to the original document, it is reflected in the submission.

The eCTD is still an evolving standard, with a number of different interpretations and region-specific guidelines, and some work still needs to be done both in the industry and by regulatory agencies. However, it is vital that life sciences organizations start building a strategy for transition to the eCTD. Early adoption of new technology and processes will help companies to retain competitive advantage.

"Electronic submissions help reviewers find the information they are looking for quickly and reliably. But equally important is that it serves as a catalyst for companies to refine their internal processes relating to how documents and data are authored, reviewed and approved and ultimately submitted," concluded Harris. "It is an opportunity to streamline the flow of information and to minimize the amount of work at the conclusion of the process. In doing so, companies will be able to get a submission out the door faster and get their drugs to the market quicker."

For more information about Livelink ECM - Collaborative Submissions, go to: Open Text Pharma and Life Sciences Solutions

About Open Text

Open Text, an enterprise software company and leader in enterprise content management, helps organizations manage and gain the true value of their business content. Open Text brings two decades of expertise supporting 46,000 customers and millions of users in 114 countries. Working with our customers and partners, we bring together leading Content Experts™ to help organizations capture and preserve corporate memory, increase brand equity, automate processes, mitigate risk, manage compliance and improve competitiveness. For more information, visit http://www.opentext.com.

Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995
This news release may contain forward-looking statements relating to the success of any of the Company's strategic initiatives, the Company's growth and profitability prospects, the benefits of the Company's products to be realized by customers, the Company's position in the market and future opportunities therein, the deployment of Livelink and our other products by customers, and future performance of Open Text Corporation. Forward-looking statements may also include, without limitation, any statement relating to future events, conditions or circumstances. Forward-looking statements in this release are not promises or guarantees and are subject to certain risks and uncertainties, and actual results may differ materially. The risks and uncertainties that may affect forward-looking statements include, among others, the failure to develop new products, risks involved in fluctuations in currency exchange rates, delays in purchasing decisions of customers, the completion and integration of acquisitions, the possibility of technical, logistical or planning issues in connection with deployments, the continuous commitment of the Company's customers, demand for the Company's products and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission (SEC), including the Form 10-K for the year ended June 30, 2007. You should not place undue reliance upon any such forward-looking statements, which are based on management's beliefs and opinions at the time the statements are made, and the Company does not undertake any obligations to update forward-looking statements should circumstances or management's beliefs or opinions change.

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Brian Edwards

Rich Maganini