In April 2022, the United States Food and Drug Administration (US FDA) took a significant stride toward modernizing the Regulatory process by releasing guidance on the electronic submission of promotional materials for human prescription drugs. The guidance, titled “Providing Regulatory Submissions in Electronic and Non-Electronic Format — Promotional Labeling and Advertising Materials for Human Prescription Drugs,” outlines the requirements for electronic submissions and highlights the benefits they offer. Moreover, the USFDA now allows for grouped submissions of promotional materials in the electronic Common Technical Document (eCTD) format.

In this blog, we shall explore the key aspects of the guidance, discuss the benefits of electronic submissions, and look at the process of grouped submissions.

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Electronic Submissions for Promotional Materials

The USFDA’s guidance mandates that all promotional materials for human prescription drugs, such as advertisements, labeling, Direct-to-Consumer (DTC) materials, medical journal articles, and scientific presentations, must be submitted electronically in the eCTD format. The eCTD format is widely adopted in Regulatory submissions since it allows for efficient electronic reviews by the USFDA. This, in turn, results in faster review processes and timely product approvals.

Exemptions and Paper Format Submissions

While electronic submissions are required for most promotional materials, the USFDA exempts materials that are less than ten (10) MB in size. However, these smaller promotional materials can still be submitted in paper format. It is crucial to consider the benefits that electronic submissions offer, including improved efficiency, accuracy, and security.

Benefits of Electronic Submissions

Here are some of the key benefits of adopting electronic submissions:

  • Enhanced Efficiency: Electronic submissions enable streamlined processing by the USFDA, thereby accelerating reviews and product approvals. This ensures that patients are able to access vital medications faster.
  • Improved Accuracy: Unlike paper submissions, electronic submissions undergo automated error checks during the submission process. This reduces the likelihood of errors, ensuring greater accuracy and integrity of the submitted materials.
  • Heightened Security: Electronic submissions are transmitted over secured networks; they utilize encryption measures to protect sensitive information. This, in turn, enhances data security and mitigates the risk of unauthorized access or data breaches.

Grouped Submissions of Promotional Materials in the eCTD Format

In addition to electronic submissions, the US FDA now allows for grouped submissions of promotional materials in the eCTD format. Grouped submissions offer several advantages, including:

  • Streamlined Process: Grouped submissions enable the USFDA to review and process materials more effectively. As multiple items are consolidated into a single eCTD file, the Regulatory review process becomes more efficient, leading to quicker reviews and timely approvals.
  • Enhanced Precision: Grouped submissions undergo automated error checks, which minimizes the possibility of errors, as compared to individual submissions. This guarantees a heightened level of precision and uniformity across all submitted materials.
  • Protected Confidentiality: Grouped submissions undergo the same rigorous security measures as individual electronic submissions. They are securely transmitted over protected networks, which ensures that the confidentiality and integrity of the promotional materials are maintained.

Submitting Grouped Submissions via ESG

Grouped submissions can be submitted to the USFDA through the Electronic Submissions Gateway (ESG), a web-based portal designed for Regulatory submissions. You can follow the three (03) steps highlighted below to submit grouped promotional materials via the ESG:

  1. Create a New Submission: Access the ESG portal and initiate a “new submission” for the grouped promotional materials.
  2. Select eCTD Format: Choose the “eCTD” format for the submission, ensuring compliance with the electronic submission requirements.
  3. Upload the eCTD File: Upload the eCTD file containing the grouped promotional materials to the ESG platform.

The USFDA’s guidance on electronic submissions and grouped submissions marks a significant advancement in the Regulatory landscape of promotional materials in the pharmaceutical industry. By embracing electronic submissions, stakeholders can streamline the review process, improve accuracy, and enhance data security. Leveraging grouped submissions further amplifies these benefits, facilitating a more efficient and effective approval process. To optimize Regulatory processes and gain a competitive edge, reach out to Freyr. Get tailored Regulatory solutions and expert guidance from us in your journey toward compliance.


Sonal Gadekar


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