Structured Product Labeling

Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information.(1)

US FDA adopted SPL technology for processing and managing labeling and labeling changes, including the content of labeling submitted electronically. In the year 2005 FDA released Guidance for Industry “Providing Regulatory Submissions in Electronic Format — Content of Labeling” for submitting the content of labeling using the Structured Product Labeling (SPL) standard, which is based on extensible markup language (XML).

The guidance addresses the issues related to the submission of labeling content in electronic format for marketing applications for human drug and biologic products, including new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biological license applications (BLAs) for biological products that meet the definition of drug in US’s Federal Food, Drug, and Cosmetic Act.(2)

DDReg’s team of highly qualified and experienced labelling professionals not only author & develop package inserts & medication guides for submission to US FDA, but they are also highly competent in converting them to XML-format SPL files, while maintaining compliance with the FDA guidelines. We provide seamless support to various pharmaceutical organizations including but not limited to healthcare, medical device, and biopharmaceutical organizations, in converting their labels to validated SPLs, and conduct version-controlled processes to manage the SPL life cycle in accordance with the FDA requirements and specifications.

(1) Structured Product Labeling Resources | FDA
(2) Guidance for Industry – Providing Regulatory Submissions in Electronic Format – Content of Labeling (fda.gov)

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