4 Tips for Implementing the FDA’s Guidance on Electronic Submissions

Get ready for the FDA’s June 2021 deadline

In 2019, the FDA finalized its guidance on the electronic submission of promotional materials. By June of 2021, organizations must submit promotional materials electronically (via eCTD) for the following two types of submissions:

  1. Post-marketing submissions of promotional materials using form FDA 2253
  2. Pre-submission of promotional materials for accelerated approval products

The final guidance outlines requirements that impact everything from how to display promotional materials electronically to titling them in the submission package. Due to its complexity, the document will impact multiple stakeholders across commercial and regulatory organizations.

To prepare for the June 2021 deadline, Veeva recommends companies focus on four key areas:

  1. Fostering collaboration between commercial and regulatory teams
  2. Define processes for material submission and maintaining a single source of truth
  3. Identify technology and opportunities to automate your process
  4. Practicing often

1. Foster collaboration between commercial and regulatory

Submitting electronically and complying with the FDA’s guidance will require marketing and regulatory teams to work together across the entire process. This process also introduces a new role to the ad promo submissions process: eCTD Compliance Package Publisher. Since compliant ad promo package creation begins with marketing, it’s important for them to involve regulatory upfront to simplify activities downstream.

Although the deadline for the FDA’s guidance is months away, evaluating and implementing changes takes dedicated time and effort. Prepare your stakeholders and give teams time for getting used to new processes. Create a clear timeline, milestones, and tasks to address this change and meet the deadline. This ensures that everyone understands expectations, understands their role in the plan, and is working towards the same goal.

2. Define processes for material submission and maintaining a single source of truth

The FDA’s guidance provides specific requirements for presenting promotional content in the transferred submission package. To help teams get started, the FDA provides seven examples of how to lay out materials.

Teams will have to align on how to organize their materials and should document this process to ensure everyone understands these SOPs. Develop a company-wide playbook with information on what to include in the package, how each of the documents will be created, and who is responsible for each step in the process. Ensure that the playbook takes into account the nuances of all promotional content types such as websites, emails, banner ads, printed materials, etc.

Defining your process for materials submissions also presents an opportunity to refine the approach for maintaining a single source of truth across commercial and regulatory teams. A simple use case is to determine how and where both teams find the current product label. Only when teams agree on the final standards, process, and roles (and communicate updates to agency partners) can they begin to implement their eCTD submission strategy.

3. Identify technology and opportunities to automate process

Often, commercial and regulatory teams use different technology solutions (or none at all) to create the submission package, approve it, and submit it to the FDA. Identifying the right technology and finding harmony across these solutions is critical to having an end-to-end workflow that reduces confusion, redundancies, and re-work.

Once the overall processes and roles are created, teams should map out how each solution supports the submissions process and where formal integrations can reduce compliance risk. Teams should also complete tasks upfront, such as bringing forward annotations and setting up automatic claims linking, to reduce manual work downstream. Identifying and investing in ways to automate certain steps will ultimately save time and money long-term.

4. Practice often

Once an organization begins to submit promotional materials via the gateway, they cannot revert to the paper or CD process. Due to the nature of these submissions, there is little room for error – so practice will be key. Organizations should build time into the plan to test the process with existing or demo assets to ensure all parties are clear on the steps, and any gaps are identified well in advance.

Get started today

At first look, the FDA’s guidance may appear complicated for teams who have never submitted promotional materials through the gateway. However, the electronic process isn’t much different from a paper submission – it simply requires teams to reevaluate, collaborate, and define new ways of working.

Organizations should take the opportunity to not just meet the requirements but also streamline their processes and systems to optimize their internal and external communication.

June 2021 is closer than it may seem – get started today.

Learn how to meet these FDA requirements in this on-demand webinar.

Interested in learning more about how Veeva can help?