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Overview
This white paper is intended to be used as an educational tool to assist the reader in the following areas:
- Develop a deeper understanding of Structured Product Labeling (SPL)
- Discuss the goals and benefits of SPL
- Understand the impact that SPL will have on your current labeling process
- Identify additional resources for broadening SPL knowledge
There are multiple sources of information (presentations, meetings, Web sites, and documents) that address SPL, including the FDA Draft Guidance entitled "Providing Regulatory Submissions in Electronic Format ? Content of Labeling," Health Level 7 (HL7) Structured Product Labeling Specification, SPL Implementation Guide, and the FDA Web site. These can be accessed from the locations defined in the SPL Resources section of this document. This paper is meant to augment, not replace, existing SPL information and attempts to pull many of the topics from these various sources together into a single, comprehensive document.
Who Should Read This Document
This document provides a comprehensive overview of SPL, covering both business and technical topics. As such, this document is appropriate for the following roles that have responsibility for labeling content within pharmaceutical and biotechnology companies, or other firms impacted by the FDA Guidance on Labeling Content.
- Regulatory Affairs Managers and Directors
- Labeling Managers and Directors
- Information Technology Managers and Directors
- Informatics Resources
- Scientific Writers
- Other roles responsible for creation, management and submission of labeling content to the FDA
Executive Summary
In today's complex, global life sciences marketplace, the ability to manage product information is a daunting task. Many departments across the enterprise use the approved product information for a variety of purposes, including package and labeling, promotional materials, and product Web sites. It is common practice for each department to take a copy of the approved content and re-create it for its own use, leading to significant process inefficiencies and potential for inconsistent product information.
Additionally, there are many consumers of this product information including regulatory authorities, academic research centers, health care professionals, and the general public. These people depend and rely on accurate and consistent information about drug products independent of the manner in which they access this information, whether through paper-based, electronic, or other channels.
The ability to ensure greater control over this critical product information has led to the development of a standard for product labeling. This standard, known as Structured Product Labeling, is being adopted by the FDA to assist in greater patient safety and increased usability of product information across its consumer base.
In 2005, the FDA will mandate the use of Extensible Markup Language (XML) that is compliant with the Structured Product Labeling (SPL) standard for electronic submissions. The goals of SPL include:
- Making available timely and accurate product labeling information
- Facilitating review, storage and distribution of labeling content
- Ensuring human readability and machine processing of labeling content If your company has not begun to think about SPL, now is the time to start. To ensure compliance, you will be required to:
- Convert new and existing labeling content to XML
- Submit to the FDA both the narrative labeling content and drug listing information
- Maintain consistent product information across all package, label, and promotional outputs
Although various options exist for submitting SPL-compliant files, creating and managing labeling content in XML has significant advantages over bolting on an SPL solution on top of traditional authoring approaches. Structured labeling content can help your organization address key business drivers such as:
- Reducing non-compliance risk by eliminating redundant sources of product information and ensuring all documents contain the correct information at all times and adhere to emerging health authority standards
- Improving the quality of product information outputs and reducing the time and cost associated with managing product information by eliminating manual tasks associated with the creation, review, approval and publishing of labeling content for multiple outputs
- Increasing efficiency of labeling content management processes and improving overall time to market
What is SPL?
In February 2004, the FDA issued a Draft Guidance requiring the electronic submission of labeling content to be provided in an XML-based format called Structured Product Labeling (SPL).
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