Preparing and submitting relevant product data is a critical step in gaining regulatory approval for new drugs and biologics in the pharmaceutical industry. To streamline the process of evaluating this data, health authorities usually require pharma companies to make their regulatory submissions using standardized formats. 

The electronic Common Technical Document (eCTD) is one such format, endorsed by numerous global regulatory agencies, including the Food and Drug Administration (FDA).

Understanding how to properly prepare eCTD submissions can help you get your pharmaceutical product onto the market faster by facilitating a smoother and more efficient regulatory review.

In this guide, we’ll tell you everything you need to know about eCTDs, including the key components of these documents, the steps involved in preparing them, and some best practices for ensuring accurate, complete, and compliant submissions.

Keep reading.


eCTD: A Brief Overview 

The electronic common technical document (eCTD) is an internationally recognized format for presenting data and information about novel pharmaceuticals to health authorities for regulatory review.

eCTD is the digital version of the Common Technical Document (CTD). The latter is a paper-based standard initially developed in 2000 by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) to harmonize regulatory submissions for marketing authorizations in the US, Europe, and Japan.

eCTD represents another step forward in the streamlining of regulatory reviews in the pharmaceutical and healthcare industry. It aims to create an even more efficient submission and review process, notably eliminating the need to manage and maintain huge volumes of paper documentation, as was the case with the original CTD.

Today, eCTD is the standard and official format for submitting applications, reports supplements, and amendments to several of the world’s leading health authorities including:

  • The Federal Drug Authority’s (FDA) Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CBER)
  • The European Medicines Agency (EMA)
  • Japan’s Pharmaceuticals and Medical Devices Agency (PDMA)
  • Health Canada
  • The Swiss Agency for Therapeutic Products (Swissmedic)


Why is eCTD Important?

eCTD streamlines and standardizes the submission of regulatory information, making it easier for the relevant health agency to access and review it. The ultimate outcome is a more efficient and speedier review and approval process.


Types of Submissions that Require the eCTD Format

Each country or region has its own set of rules about the kinds of applications that must be submitted in eCTD format. For example, in the US, it’s a requirement for the the following applications to be an eCTD submission:

  • Investigative New Drug Application
  • New Drug Application (NDA)
  • Abbreviated New Drug Application (ANDA)
  • Master files, including the Drug Master File (DMF) and Biologics Master File (BMF),
  • Emergency Use Authorization (EUA)


Key Components of an eCTD Submission

An eCTD submission comprises five main modules, each serving a specific purpose in the regulatory review process.

  • Module 1 (Regional administrative and prescribing information): This part of eCTD contains administrative and prescribing information specific to each region (such as the U.S. FDA or European EMA).
  • Module 2 (Common Technical Document Summaries): This module contains high-level summaries and overviews of three main elements: quality, safety, and efficacy.
  • Module 3 (Quality Data): Module 3 of eCTD focuses on the quality of the drug or biologic. It includes a description of its chemical structure, the manufacturing process, and its characteristics.
  • Module 4 (Non-Clinical Study Reports): This module includes non-clinical, i.e., pharmacokinetic, pharmacological, and toxicological study reports of the drug or biologic.
  • Module 5 (Clinical Study Reports): The final module detailed information and results from all clinical studies or trials conducted with the drug or biologic.


Who Prepares eCTDs?

eCTDs are typically prepared by a team of experts who might include regulatory affairs specialists, scientists, medical writers, and IT professionals. Their collective goal is to ensure that the submission is not only compliant with the regulatory guidelines but also clear, concise, and scientifically sound. 

The involvement of multiple experts and stakeholders within the eCTD preparation process is one of the reasons why having a secure file-sharing and collaboration tool is crucial. Hosting the collaboration necessary to compile the documents in a virtual data room like CapLinked not only helps keep confidential information secure, but makes it much easier for experts across companies and time zones to collaborate effectively. 


How to Prepare eCTD Documents

Preparing eCTD documents involves several crucial steps to ensure compliance. Let’s go over these steps.


1. Familiarize Yourself with the Relevant Guidelines

The first step is to familiarize yourself with the relevant regulatory authority’s (e.g., the FDA) guidelines for eCTD submissions. These guidelines describe the required format, structure, and content of the documents. They also include specifications for file formats, hyperlinks, bookmarks, and the organization of the eCTD’s five modules.


2. Gather Documents

Collect all necessary documents that need to be included in the eCTD. These include administrative information, summaries, study reports, administrative information, and so on. Ensure all documents are up-to-date and complete.


3. Format Documents Appropriately

Format each document according to the submission document guidelines of your health authority. For instance, for eCTD submissions to the FDA, this might mean converting the documents into PDF files, ensuring they are searchable, and adding bookmarks and hyperlinks where required. Pay attention to details like font size, margins, and file naming conventions when making electronic submissions.


4. Structure the eCTD

Organize your module documents according to the eCTD structure. Ensure each document is placed in the correct module.


5. Create the XML backbone

eCTDs require an XML backbone that basically acts as a table of contents, linking all the documents and metadata. This backbone is essential for navigating an eCTD and ensuring all documents are accessible and organized. You can create the XML backbone using an eCTD publishing tool, like Certara.


6. Validate the eCTD

Before submission, it’s critical to validate the eCTD to ensure it meets all technical requirements. This can be done using eCTD validation software, which checks for common errors and ensures compliance with the necessary guidelines.

Having completed the steps above, your eCTD is now ready for electronic submission.


Trust CapLinked to protect your confidential information and streamline your workflow.

The eCTD Submission Process

While the eCTD format is harmonized to a great extent, there are specific regional requirements and differences in the submission process for each regulatory agency. Visit your local regulatory agency’s website to learn more about its specific requirements or process. 

If you’re in the US, here are the steps for making an eCTD submission to the FDA.

  1. Go to the FDA website and register for an Electronic Submissions Gateway account. The FDA advises that you register an account as early as possible, as the sign-up process can take some time.
  2. Request an application number. You’ll need a pre-assigned application number before you can submit your application to the FDA. More details about this are available on the FDA website. 
  3. Send a sample submission to the FDA. This step is optional, but it can help you identify any technical issues that you might face when making your actual submission and correct them beforehand.
  4. Submit your eCTD via the Electronic Submission Gateway. As mentioned earlier, ensure to validate your eCTD using appropriate software before submission to avoid any submission errors.


eCTD Submission Best Practices

While the eCTD submission requirements or steps might differ from one regulatory agency or one region to the other, there are several universal best practices you can follow to ensure a smooth process. Let’s look at a few of these best practices.

  • Stay updated with regulatory guidelines: Regulations are constantly changing and evolving in the pharmaceutical world, so make sure to stay informed. Regularly check for submission requirement updates, technical specifications, and industry standards.
  • Make a plan: Having a plan with specific timelines, milestones, and responsibilities for each member of your team can help ensure a successful submission. The plan can act as a roadmap, guiding you through each part of the submission of your regulatory documents, and can help make sure that no critical elements are overlooked.
  • Leverage eCTD software and tools: Leverage specialized eCTD software for different parts of the process, including the compilation and validation of your documents. These tools can help you work faster, avoid errors, and ensure compliance with the necessary standards and guidelines.
  • Get your submission reviewed by a qualified professional: Before the final submission, have a regulatory expert review the entire package for compliance and completeness. They can cover any issues that might have been overlooked and identify areas that are prime for improvement.
  • Engage with regulatory agencies: Don’t hesitate to reach out to the relevant regulatory agency if you have any questions or concerns about the eCTD submission process. Most are willing to provide guidance and clarify any uncertainties you may have.


Wrapping Up

Preparing documents that don’t conform to eCTD standards or requirements can lead to delays in getting relevant approval for new drugs or biologics that you’re trying to get onto the market. 

To avoid that, ensure you’re familiar with and fully understand all the relevant eCTD submission guidelines for your relevant agency — whether it’s the FDA, the EMA, or any other regulatory authority.

Having a platform where you can securely share documents and files is also critical during this process. After all, the falling of sensitive documents into the wrong hands can lead to irreparable harm.

For all your secure file-sharing needs, look no further than CapLinked. With features like military-grade encryption, permission controls, and audit trails, CapLinked’s virtual data rooms (VDRs) ensure that your confidential or sensitive documents and files are protected during the eCTD submission process and that they’re accessible only to authorized personnel.

CapLinked takes care of your document security needs, leaving you to focus on the accuracy and quality of your eCTD submissions.


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FDA: Requesting a Pre-Assigned Application number

FDA: Getting Started: Creating an ESG Account

Celegence: Overview of eCTD Submission Modules and Format

ProClinical: Marketing Authorisation: the goal of pharmaceutical regulatory affairs


Sean LaPointe is an expert freelance writer with experience in finance and tech. He has written for several well-known brands and publications, including The Motley Fool and Angi/HomeAdvisor.