Speed and efficiency: The role of automation in an increasingly eCTD world

By Sadia Ahmed and Marcy Miller, DXC Life Sciences

The world of the electronic Common Technical Document (eCTD) is closing in on life sciences companies, irrespective of size. The U.S. Food and Drug Administration (FDA) now requires the use of eCTD for all New Drug Applications (NDAs), Abbreviated NDAs, and Biologics License Applications (BLAs), and as of May 5, 2018, that requirement will be extended to the Drug Master File (DMF) and Investigational New Drug applications (INDs).

The same is true in Europe, where eCTD is now mandatory in all but the National Procedures. Further compounding the eCTD demands placed on companies, a growing number of regions either have or are adopting their own eCTD formats, including Thailand, China, Brazil and others.

Companies are now being pushed to meet eCTD mandates, and many are seeking to expand their market presence, leading to a growing need for a more efficient way to manage eCTD submissions.

With eCTD 4 around the corner, the need for flexibility and expertise is crucial. Companies should select an eCTD partner that supports the conversion of data from eCTD v3.0 to eCTD v4.0, but at the same time, one that has the flexibility to support eCTD v3.2 based on regional needs.

Improving workflow and processes

When a product is introduced to new markets, it increases the workload for regulatory departments, requiring an adaptation to different regulations and often forcing companies to implement applications and processes from scratch. Therefore, it’s important to have a solution that is flexible in supporting multiple regional needs.

Automation presents opportunities to improve processes and workflow when preparing eCTD submissions in existing markets, and/or expanding into new markets. As companies consider automation for eCTD submissions, it’s also important to consider the capabilities that will benefit and drive efficiency.

Automation can be done in many ways, such as reusing existing submission content and transforming it into a new eCTD for the same or a different region more rapidly. The ability to automate the process of gathering content from other solutions, such as the document management solution, makes it possible to build an eCTD faster.

Planning is another important functionality, since it allows companies to keep track of their submissions and know immediately what is required in each region. For example, if you’re submitting in multiple regions, you want a tool that informs you whether a study is due in a particular region or whether a regulatory authority is awaiting a response, what resources are required, what content needs to be submitted, and so on. Automating the planning process allows you to manage all these varying requirements seamlessly, alerts stakeholders about their responsibilities, and informs senior management of potential bottlenecks in the process. Currently, some companies are attempting to prepare their own simple planning tools by using databases, but this is a time-consuming, manual activity.

Another important consideration when selecting a solution and partner is flexibility to meet current and future needs, and to adapt to each company’s infrastructure and process setup.

Finally, proven know-how with eCTD is crucial. How you manage your submissions will depend on your success in getting through the regulatory process. The opportunities automation brings must therefore go hand in glove with proven technology.


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