Submitting Electronic REMS Documents: What You Need to Know [2023]
Back in 2020, the U.S. Food and Drug Administration (FDA) issued guidance saying that pharmaceutical companies must submit all REMS documents electronically within two years. Well, the time has come.
Starting December 28, 2022, pharmaceutical companies must submit REMS documents electronically.
What exactly are these REMS documents, and why are they going digital now? Let’s take a look.
What Is a REMS?
A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program for high-risk medications. While all drugs pose risks, some have more serious safety concerns than others. To help keep consumers safe, the FDA can require specific medications to be part of a REMS.
The goal is to keep tabs on the medication and ensure the benefits of using the drug outweigh the risks. This is accomplished by teaching pharmacists, prescribers and patients when and how to take the medicine to avoid frequent or severe adverse reactions.
For example, if a drug has the possibility of causing severe congenital disabilities, a possible REMS action would be for the patient to show a negative pregnancy test before the pharmacist dispenses the medicine.
Every medication has a pharmaceutical label that explains how, when and why to use it. But only a small selection of medications is part of a REMS.
How Is a Drug Added to a REMS?
In order for a medication to be marketed and sold in the U.S., the pharmaceutical company must submit a Structured Product Label (SPL) document that contains all the product information for the drug. In addition, if the FDA determines the medication requires a REMS, the pharmaceutical company must submit a proposed REMS along with its application.
There are a few different types of drug applications:
- New drug applications (NDAs): A request to market and sell a new brand-name drug.
- Abbreviated new drug applications (ANDAs): A request to approve and market the sale of a generic drug.
- Biologics license applications (BLAs): A request to introduce a biologic product into interstate commerce.
Until recently, REMS documents could be submitted on paper or electronically. But starting December 28, 2022, the FDA will require all REMS submissions to be electronic. Here’s why.
Why Do REMS Need to Be Submitted Electronically?
The Problem
The FDA published a report called Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS), which detailed the struggles prescribers and pharmacists faced with REMS documents. Here were some of the biggest takeaways:
- REMS materials and requirements could be hard to locate.
- Stakeholder requirements weren’t clearly outlined, causing confusion.
- Integrating REMS materials with existing health information systems needed to be easier.
The Solution
As a result of the feedback, the FDA required all applicants of NDAs, ANDAs, and some BLAs to submit REMS documents in SPL format. The goal: to standardize the information in REMS documents so that stakeholders can save time trying to understand what’s required of them. And the electronic format also allows stakeholders to easily integrate their REMS documents into their existing health information systems.
How to Submit Electronic REMS Documents
There are two main ways to submit electronic REMS documents: SPL submission software and SPL outsourcing service.
SPL Submission Software
SPL submission software enables you to send SPL files to regulatory authorities. For REMS documents, all you need to do is upload your information into the software so the Word-XML markup can convert your label content into metadata. From there, you can submit the SPL file to the FDA for approval. This would need to be done for every medication that requires REMS.
SPL submission software takes the guesswork out of REMS documents, which allows your stakeholders to handle their requirements faster and more effectively.
SPL Outsourcing Service
If you don’t want to invest in SPL submission software, you can always outsource your SPL filing to a dedicated team. There are regulatory experts available who can take your paper REMS documents and convert them into an electronic format. Then, they can handle the SPL submissions on your behalf so you can focus on other aspects of your business.
It helps to work with SPL experts who have a solid relationship with the FDA. That way, your SPL consultants can work with the FDA if there are any issues with your SPL submissions. Your dedicated SPL experts will also be able to make any necessary adjustments to get your electronic REMS document approved.
Conclusion
The time has come for all REMS documents to be submitted electronically. This will standardize REMS information and make it easier for pharmaceutical companies to integrate the files into their health information systems.
Intagras offers state-of-the-art SPL submission software, SPL Portal, that makes it easier than ever to manage electronic REMS documents. SPL outsourcing is also available if you require a dedicated team for assistance. Contact us to learn more about our offerings.
Need SPL submission help? Talk to us.
Have questions? Need more info? Talk to one of our experts or request access to our SPL Portal.
