As regulatory agencies such as the U.S. Food and Drug Administration (FDA), and parallel agencies in Europe, Japan, and Canada, move toward a completely electronic submission environment, tools like templates for Microsoft Word® become increasingly essential to submissions content development processes. Templates can be essential during the preparation of electronic common technical documents, or eCTDs. The eCTD is a standard created by the International Conference on Harmonisation (ICH), a consortium of regulators from Europe, the United States, and Japan, who developed a common standard for marketing applications for drug and biologic marketing applications in those geographic areas.
Along with the introduction of the eCTD, the concept of granularity was also introduced. In essence, those components of eCTDs that are written in regards to the safety, quality, and efficacy of a drug or biologic product are prepared in much smaller units than earlier formats for submissions. This granularity allows such units to be updated over the course of a marketing application without having to resubmit an entire large unit for review by a regulator. As a result, guidances have been issued by the FDA and ICH instructing industries to supply PDF documents with eCTD submissions to required levels of granularity. Not only must the bulk of e-submissions be available in PDF format, but they must also be complete with tables of contents, contain bookmarks and hyperlinks, have eCTD module-specific numbering and text in page headers, be of highly-constrained page size, and be optimized for legibility in an electronic submission review tool. In this sense, templates assure compliance with eCTD granularity and PDF format specifications by their very nature if they have been designed to be compliant with FDA and ICH requirements for PDF files.
Templates can streamline submissions processes by providing a uniform appearance across all content of the dossier. Effective templates allow content to be reused throughout the submission, meaning that the same voice is used to describe the drug product and mechanism of actions. This aspect of good templates can insure that a cohesive story is being told across not only the initial application but also in all accompanying sequences.
A robust template offering will also typically include common functions in toolbars and styles, which can dramatically reduce the total number of keystrokes required for assuring the document formatting converts to compliant PDF files. This enables those individuals in an organization who are responsible for entering the technical content of a submission to focus on content rather than being concerned with standardizing format elements such as headings, table figures, table titles, and such. With an effective template offering, the consistency of appearance is already taken care of for the author.
Another helpful characteristic of a template package is that it can help a company enforce its own standards and conventions, such as:
Other key features of effectual template packages that can help a company authoring content intended for marketing applications include:
When selecting a template package, all the topics discussed above should be taken into account, as should the following items:
Implementing templates can drastically save a company's time and resources—not to mention accelerate submissions processes and, ultimately, a product's time to market—but purchasing a templates package is a major step for any company. Prior to selecting a template package you should have the confidence that the vendor's offering can effectively lead you through the processes of producing and managing an eCTD and that the templates possess the robustness necessary to adapt as electronic submission regulations develop and change through the years.
Antoinette Azevedo founded www.e-submissionssolutions.com to advise all sizes of biotechnology and pharmaceutical companies on the use of technology to manage regulatory documents and publish electronic submissions. Her clients range from large, international pharmaceutical companies to small, virtual biotechnology companies. Antoinette was director of West Coast Operations for Liquent from 1997 to 2000. She was principal consultant in the CSC Consulting life sciences practice as technical lead for regulatory submission publishing from 1994 to 1997, working with pharmaceutical clients in North America and Western Europe. Her entire career has been devoted to document management and electronic publishing through several generations of technologies and architectures in various industries. Antoinette has lectured internationally for RAPS and DIA, at vendor-user conferences, and for local regulatory affairs professional groups.
Read more about electronic submissions:
Providing Regulatory Submissions in Electronic Format - Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications
FDA Guidance for Portable Document File Specifications
Guidance for Industry — Providing Regulatory Submissions in Electronic Format â€“ General Considerations