According to the Common Technical Documents (CTD) website, endorsed by the ICH, Canada and some European countries require use of CTD as of July 2003. This does not refer to use of electronic eCTD. Links to a free eCTD reviewing tool and sample eCTD submission can be found on this site. More information can be found on website of Oasis, a non-profit organization promoting e-business standards.
Guidelines for submitting an eCTD for approval in Canada can also be found online. Canada accepted a limited number of eCTDs from 2004 to 2006, and began a pilot project for acceptance of hybrid CTD/eCTD acceptances from April to June 2006. These resources providing online information are geared towards helping small startups depending on non-IT personnel, managing operations in a biotech atmosphere.
The Benefits to Using XML Authoring
An XML-based content management system is obviously of more use to larger organizations. The benefits of such a system increase with increasing number of authors and document complexity. However, the advantages for small (startup) biotechnology companies include document standardization, profiling and growth. This means everyone uses the same template for documents, with no accidental changes along the way as could happen when documents are prepared and shared via Word- or other word processing software-based systems.
XML keeps content and structure of documents separate from style, and can be used to prepare several different types of documents, of different structures all from the same content. An online authoring environment tailored to the company's specific content production needs can save up to 50% of a content author's time that is normally spent on formatting, layout and review.
Small biotechnology companies can begin by researching the recent new and proposed government regulations, and plan ahead by implementing an electronic content management/ dynamic content publishing plan, early on. This plan should be based on the expectation that they intend to apply in Canada or Europe to market their products, or that they will soon require it to license drugs in the USA. A strategic approach to good content management from the very start is to take into consideration the types of content that will be managed and develop a plan for managing it through the product or company's entire life-cycle.
It is then important to have a structured system for content creation, review and approval and enforce adherence to this system. This philosophy is not so different from the structured approach to business and document management that is reflected in the ISO Quality Management Systems. Like ISO certification, use of a structured document management system is likely to increase company productivity and efficiency, and reduce errors - a goal that is shared by all biotechnology companies, big and small.
Sources: Douglas May. The Case for XML Authoring and Content Life-Cycle Management: Strategies to Enhance Compliance and Improve Operating Efficiency. Bioprocess International, June 2006.
Douglas May. The Case for XML Authoring and Content Life-Cycle Management: Strategies to Enhance Compliance and Improve Operating Efficiency. Bioprocess International, June 2006.