How to include the REMS for NDAs, ANDAs and BLAs in SPL format?

FDA has released a guidance document for Providing Regulatory Submissions in Electronic Format


FDA has just released a guide to include them and in two years it will become mandatory

FDA has released a guidance document for Providing Regulatory Submissions in Electronic Format - Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling.

This guidance document provides information on how to include the REMS (The Risk Management Plan in US) for NDAs, ANDAs and BLAs in SPL format. 

Applicants must submit the content of their REMS document in SPL format, 24 months after this guidance is finalized.  A submission that doesn´t comply and will not be filed or received by FDA.

In case of any question with regards to REMS or SPL format, please contact ASPHALION at


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