In late December 2020, the FDA issued the Final Guidance on REMS (Risk Evaluation and Mitigation Strategy) submissions in Structured Product Labeling (SPL) format. While participation is currently voluntary, and has been since September 2016, compliance with this guidance will be required as of December 28, 2022.
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.
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.
At Reed Tech, we specialize in understanding the key aspects of medical device regulations both in the U.S. and around the globe. Contact us for help with medical device product management and regulatory data submissions. Email us: MedDevice@ReedTech.com or Pharma@ReedTech.com or call 215-557-3010.