Proceedings

Abstract:

Pharmaceutical and biotechnology companies are required by law to compile and maintain over a multi-year life-cycle, large and complex collections of documents for submission to national regulatory agencies in order to obtain and sustain marketing approval for drugs and biologically active substances. The content includes both data and textual narrative, and is of great value in terms of intellectual property and legal liability. Over the past few years a cooperative effort between the regulators and industry has developed XML-based standards for electronic submission.

First came the electronic Common Technical Document (eCTD), specifying an XML 'backbone' to identify and organize the PDF files of a submission and define the way in which they alter the existing file set for the product. Now, XML standards are being developed for submission documents themselves. Through HL7's Regulated Clinical Research Information Management TC representatives of the stakeholder communities have defined Structured Clinical Trial Protocol (SCTP) documents, and Structured Product Labeling (SPL) documents. Drug labeling documents comprise much more than what is written on the package: they contain the most complete and up-to date summary of a drug's quality, efficacy and safety, and as such are the most long-lived and most frequently updated of these documents.

This paper will examine the nature and use of the SPL standard. It will first present some background about pharmaceutical labeling and the business objectives for electronic submissions. It will then review key technical aspects of the standard: the way in which HL7's object-oriented Reference Information Model is represented in XML, the way in which structural and semantic markup is used to integrate data and narrative, and the way in which markup is used to facilitate life cycle management and content distribution through modular update.

Though SPL is an interchange standard, not an internal processing standard, there is value to be gained by using XML from the beginning of the documentation process rather than working in other formats and then packing content in XML as if it were a 'shipping container'. The paper will discuss the issues that this raises for conventional document authoring and management practices and systems, and identify steps that need to be taken, both on the IT side and on the business side, to achieve the maximum return on the investment in SPL.

The paper will conclude with a brief status report on implementation and trial operations.