New Draft Guidance: Providing Regulatory Submissions in Electronic Format — Content of the REMS Document Using SPL

On September 5, 2017 the U.S. Food and Drug Administration (FDA) published a draft guidance on Providing Regulatory Submissions in Electronic Format — Content of the Risk Evaluation and Mitigation Strategies (REMS) Document Using Structured Product Labeling (SPL). SPL is an electronic data standard used for capturing information about drug products and is used by the FDA as a mechanism for efficiently exchanging product and facility information. While SPL is most well known as a means for capturing labeling information, the standard has wide ranging utility beyond this purpose.  The availability of REMS information in SPL format will make REMS information more easily accessible. It will also facilitate integration into health information technology, making it easier for health care providers to comply with REMS, reducing their burden, and enhancing the safe use of drugs with REMS.

This guidance describes the benefits of utilizing SPL to submit REMS documents and explains how to submit REMS in the SPL format. It also begins the process of making the submission of REMS in SPL a requirement. Under the Food and Drug Administration Safety and Innovation Act (FDASIA), the requirement will go into effect 2 years after the draft guidance is made final. FDA encourages interested parties to submit any comments on this draft guidance via the associated docket within 180 days of September 5, 2017.