XML technology is emerging as a powerful technology in the pharmaceutical industry. Drug companies and regulatory agencies are looking to speed up the preparation and review of regulatory submissions. For a blockbuster drug, one day’s sales can equate to one million dollars in revenue. So the business drivers are strong to replace today’s PDF-based electronic regulatory submissions with “smarter” XML submissions as a way to speed time-to-market.

There are several pharmaceutical industry XML initiatives in progress, led by both US and global organizations. The Food and Drug Administration (AERS) has created an XML standard called the Adverse Events Reporting System (AERS) for reporting serious problems that occur in patients during clinical trials or prescribed drug use. Also, the FDA has established an XML-based Cumulative Table of Contents (AERS) to link Investigational New Drug Application (AERS) submissions required at various steps during the drug development process.

On an international level, the International Conference on Harmonization (AERS) is working on the Common Technical Document (AERS). The CTD is an international standard regulatory submission document. Today, submissions vary widely in content and structure by country. The CTD is aimed at having a common structure, with fewer country-specific requirements. From a technology perspective, the Electronic Common Technical Document (AERS) has been developed, an XML standard "backbone", or outline, to help navigate the documents in a CTD and across multiple eCTD submissions. Product Information Management (AERS), an initiative of the European Agency for the Evaluation of Medicinal Products (AERS), leverages the power of XML in the preparation and review of European drug labeling regulatory submissions. International XML standards for Clinical data (ODM and SDM) are being driven by Clinical Data Interchange Standards Consortium (AERS). Session reviews these regulatory pharmaceutical initiatives and the current state of related industry XML standards. It looks at what technology infrastructure is required for pharma companies to successfully implement systems to produce these XML submissions. Business issues related to FDA compliance, including 21CFR Part 11 requirements, are explored. On the technical side, the current best-of-breed software tools in use by pharmaceuticals are discussed.

In non-regulatory areas, pharmaceuticals are implementing XML solutions as a way to derive efficiencies in business functions and enable reuse of their business assets. Session looks at applications where XML technology is being employed in pharmaceutical research & development, manufacturing, and sales & marketing. These include XML-based status reports, medical information system call center letters, and web content management. Session draws conclusions about how the use of XML technology will grow in the future to yield business benefit for pharmaceutical companies.