FDA: 2 years until SPL E-submission for REMS docs
The US Food and Drug Administration (FDA) has issued final guidance on the electronic submission of documents related to the Risk Evaluation and Mitigation Strategies (REMS) using the Structured Product Labeling (SPL) format. The final guidance document starts the clock on compliance, with the new formatting requirements taking effect on 28 December 2022.In the final guidance document, the FDA outlines how it will implement the requirements for e-submission of REMS documents that are part of submissions for new drug applications (NDAs), abbreviated new drug applications (ANDAs), and certain biologics license applications (BLAs). The SPL formatting applies to both new REMS documents and modifications.
REMS materials, including communication and educational materials, enrollment forms, and prescriber and patient agreements, must be referenced in the SPL file. REMS supporting documents do not need to be submitted in SPL format.
The final guidance document updates a draft issued by the FDA in 2017 (RELATED: E-Submissions of REMS Documents: FDA Offers Draft Guidance, Regulatory Focus 01 September 2017). The agency made editorial changes aimed at improving clarity and amended language to reflect the recent publication of exemption and waiver criteria for Electronic Common Technical Document (eCTD) submissions in a separate guidance.
Unlike most regulatory guidance from the agency, the final guidance document contains binding language for industry.
The final guidance comes out of a 3-year process in which FDA gathered feedback from industry and health care providers about REMS standardization. During that process, commenters told the FDA that REMS materials can be difficult to locate and that the requirements for prescribers and pharmacists are not always clear. The use of SPL is aimed at overcoming some of those challenges.
“SPL can be used to capture and present REMS information in a format that is easily shared with stakeholders and readily incorporated into health information technology,” the FDA wrote.
Specific SPL formatting requirements are spelled out in the FDA’s “Structured Product Labeling (SPL) Implementation Guide with Validation Procedures” (SPL Implementation Guide). Information on how REMS document SPL files are placed in the Electronic Common Technical Document (eCTD) is available in the “eCTD Technical Conformance Guide.”
FDA final guidance