PIM: European Drug Labeling Goes XML

ABSTRACT

Pharmaceuticals have been notorious in their late adoption of new technology. But the business case is compelling to deliver drug labeling information to regulatory agencies using XML. PIM, a consortium initiative between the EMEA (Europe's Regulatory body) and EFPIA (a pharmaceutical industry group) has taken the first step, establishing XML standards (DTDs) for delivering normalized, multilingual content and creating submissions using the standards. Even using minimal XML tools, participating companies were able to cut significantly the time and effort needed to prepare drug labeling submissions. This was largely due to the normalization of the content in XML and the dynamic assembly of the submission documents from that XML content. Projections for savings in creating "updates" to labeling documents is even greater. Beyond the savings on the pharmaceutical's side, agency review time is also reduced. Up next is the addition of content management to satisfy needs such as versioning, workflow, audit trail, and archive. The ultimate goal will be to establish two-way XML transactions between pharmaceutical company and agency. But the obstacles are many. The level of granularity of transactions must be agreed. Implementing repositories on both ends means guaranteeing that the content at the agency will be secure from access by other pharmaceuticals. Transactions must be audit trailed and the updated XML content guaranteed to match. Session will describe the challenges faced when implementing a pilot PIM content management system for a major pharmaceutical company. New authoring DTDs were created to present the content in a manner familiar to authors. Arbortext Epic Editor was configured and customized to create a workable authoring environment. Documentum 4i was used to manage the content, with XML instances "burst" into Documentum virtual documents, a three state lifecycle applied, and a simple workflow implemented. XSLT stylesheets were developed to transform authored content to the EMEA XML standard. Session will look at what worked and what didn't and the applicability of the PIM solution to US drug labeling. It will also look ahead to the issues around transaction-based submissions and the prospects of XML content management/delivery for other pharmaceutical content. PIM's compatibility with other pharmaceutical XML initiatives, including the eCTD, will also be discussed.