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New FDA Requirement: New and Updated REMS Files to be Submitted in SPL Format

Dec 12, 2022 | Drug & Biologic Product Submissions, Pharmaceutical and Cosmetics

As of December 28, 2022, all new REMS (Risk Evaluation and Mitigation Strategy) submissions and all REMS updates will be required to be submitted in SPL (Structured Product Labeling) format per the FDA. This is in compliance with the Final Guidance on REMS issued by FDA in late December 2020. This means that any current REMS registrations will not need to be submitted in SPL until they require updates. There are currently 62 active REMS—58 ETASU (Elements to Assure Safe Use) and 4 basic (non-ETASU.)

REMS includes some of the most acronyms and specific terminology that FDA has produced. Reed Tech has created a REMS glossary to help pharma companies understand this terminology.


What is REMS?

REMS is an acronym used by FDA to describe the Risk Evaluation and Mitigation Strategy initiative developed by FDA and implemented in 2007. Described as “a drug safety program that the U.S. FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.” This program has a “focus on preventing, monitoring and/or managing a specific serious risk by informing, educating and/or reinforcing actions to reduce the frequency and/or severity of the event.”

Why REMS in SPL?

FDA has chosen to transition REMS to SPL format for several reasons. In the current PDF submission model, REMS exhibit little standardization in description, format or terminology and vary widely in their ease of use. Submission of REMS in SPL will help to clarify and standardize REMS content across the industry, making FDA review procedures more efficient. In addition, REMS in SPL will increase access and ease of use for all REMS content stakeholders, including sponsors, FDA, providers, prescribers and patients, with the ultimate goal of improving patient safety.

Is your company a sponsor of a drug product requiring a REMS program? Contact Reed Tech to learn more about REMS and the advantages of submitting in SPL format. Reed Tech participated successfully in the FDA’s REMS SPL pilot program with an industry partner and has been providing life sciences companies with expert SPL submission solutions, education and support since 2005.

What is SPL?

SPL is an XML document markup standard approved by Health Level 7 and previously adopted by the FDA for electronic Drug Registration and Listing (eDRL)Unique Device Identification (UDI), Lot Distribution Reports (LDR) and other structured content submissions. Reed Tech has been managing SPL submissions for vendors since the FDA SPL program inception over 15 years ago.

Contact Reed Tech for help with your REMS in SPL submissions or other questions at [email protected] or call 215-557-3010.