Skip to main content
Home / Resources / Blog / Answers to Drug Developers’ Frequent Electronic Common Technical Document Questions

Answers to Drug Developers’ Frequent Electronic Common Technical Document Questions

Although the Electronic Common Technical Document (eCTD) has been around for many years, it continues to evolve as the pharmaceutical industry adapts to changing regulatory standards and innovative technologies. Because of the inevitable changes, the eCTD presents hurdles to regulatory operations professionals, particularly for those who desire to jump in headfirst and get started using the eCTD format. In this blog, I will share answers to some of the most frequent questions raised by those entering this space to help you get started with eCTD and remain current with the evolving format.  

Q: Why use the eCTD format? 

A: The eCTD makes it easier for the FDA and other global regulatory agencies to review data in submissions, approve new drugs, and monitor drugs once they hit the market. The eCTD is meant to simplify the review process and unify the submission format for those submitters filing to multiple countries.  

Q. What steps should I take to get started with the eCTD? 

A: You will want to begin by submitting a request for an application number from the FDA. It is also necessary to register for an Electronic Submissions Gateway (ESG) account and submit a sample submission to the ESG. Once your test submission is approved, you will be given credentials to submit in the production environment. With these steps completed, you’ll be on your way to using the eCTD for your application.  

Q: What submission types must adhere to the Electronic Submission Requirements? 

A: Certain investigational new drug applications (INDs), New drug applications (NDAs), Abbreviated new drug applications (ANDAs), and certain biologics license applications (BLAs). 

Q: How is the eCTD format structured? 

A: The eCTD contains 5 modules. Within each module, document granularity sections exist for applicable file placement of your submission contents. Here’s a breakdown of the 5 modules: 

  1. Administrative information and prescribing information 
  1. Common technical document summaries 
  1. Quality data 
  1. Non-clinical study reports 
  1. Clinical study reports 

Modular Structure of Common Technical Document


Q: What is the process for getting a submission into the eCTD format, and when should we start? 

A: The first step is to get your submission documentation into the format specified by eCTD templates. Regulatory and Medical writing teams usually write all the clinical and non-clinical studies in content templates that format everything according to eCTD regulations. These eCTD authoring templates should be used for any report planned for a regulatory filing no matter how far off the submission may be. 

Once the documentation is in the correct format, the content should be approved by subject matter experts as well as regulatory operations. Once approved, it is transferred to the publishing team which starts the submission compilation. This involves creating PDF files, adding navigation aids (bookmarks and hypertext links), and uploading them to the online eCTD publishing software, like Global Submit™. Once the publishing team has performed its process, the eCTD files and sections should be reviewed again by the subject matter experts. 

Q: What is the XML backbone, and how do we create it? 

A: The publishing software completes two major tasks automatically. First, it creates the proper folder and subfolder structure that organizes the eCTD documents by modules. It also auto-generates an XML backbone. 

The XML allows the eCTD viewing software to load the application and structure the files in their proper order over the life cycle. The XML backbone provides required metadata as well as document life-cycle operators which are loaded into the eCTD viewing tool, such as Global Submit Review

Without an XML backbone, your submission will fail the regulatory agency’s validation software. Thus, the health agency reviewers will not review your submission because it will not load into the review software. 

Q: What do people mean when they refer to the “metadata” of a submission? 

A: Metadata in the case of eCTD submissions refers to structured data. The eCTD message that is sent contains structured data. Some of the information that is entered as metadata with submissions includes the application types, sequence types, sequence numbers, Duns & Bradstreet Number (a unique nine-digit identifier for businesses), the regulatory contact’s name, and their phone number. The regulatory operations team will add this information to the eCTD publishing software. 

Don’t get too comfortable with the current metadata though because the role of metadata will be expanded with future versions of eCTD as eCTD V4.0 is implemented, particularly with potential impact on identifying medicinal products (IDMP) on Structured Product Labeling (SPL). Read more about the updates included in eCTD V4 in this blog. 

Now you know more about the structure of an eCTD submission and should feel confident about getting started preparing for and building your eCTD application today. Do you need help with eCTD publishing? Our regulatory operations experts can help. Learn more here:

*Note:  This blog was originally published on July 21, 2017, by Rob Connelly. It was updated by Carrie Ngangnang on November 20, 2023. 

 

About the author

Carrie Ngangnang
By: Carrie Ngangnang

Carrie Ngangnang is a Senior Regulatory Operations Specialist with several years of experience in regulatory operations electronic publishing, serving as project lead on multiple application types and over 20 years serving in leadership roles, managing people and projects ranging from few to 300+ stakeholders.