Implementing the Electronic Labeling Submission Standard

New technologies for the electronic processing, communication and management of labeling, based on the Structured Product Labeling (SPL) standard, are streamlining the U.S. Food and Drug Administration’s (FDA) handling of information. All manufacturers subject to the FDA’s regulatory specifications for electronic submissions must adhere to SPL requirements. FDA regulated industries, such as pharmaceutical, medical device and other Life Sciences, are facing significant changes in how they report key information to the FDA in order to comply with this new standard.

SPL is the XML document markup standard for labeling content adopted by the FDA. SPL replaces the previous standard for electronic submissions, which was based on the document centric Portable Document Format (PDF) standard. The adoption of the SPL labeling format has escalated the need for organizations throughout the Life Sciences industry to develop a new strategy for regulatory submissions.

Efficient SPL implementation requires an enterprise-wide packaging strategy encompassing labels, packages and marketing materials. This paper provides a comprehensive overview of business and technical topics that can help you successfully implement SPL guidelines.

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