Taming the eCTD

Consider the large, global conglomerate with research, development, manufacturing and supply organisations spread across multiple continents. Hundreds of authors are engaged in the preparation of thousands of documents spread over several years – all converging in a series of late stage tasks that occur in the final month or two prior to submission. Assembly of the final submission – traditionally the realm of regulatory operations professionals – has received much attention over recent years, with all manner of tools emerging to automate the formatting, publishing, hyperlinking and collation of the final ‘product’. The fact remains, however, that much of this lastminute effort amounts to unnecessary revision, fixing up things that could have been ‘done right the first time’ earlier on in the submission’s life cycle. Given the consequences of failing to comply with agency regulations, and the financial implications of missing submission deadlines, these traditional ‘panics’ are unlikely to be tolerated for much longer.

Regulatory requirements are changing rapidly, especially with the inexorable drive towards electronic submissions, and the introduction of the electronic Common Technical Document (eCTD). eCTD is having a major impact on companies large and small, since it inherently requires that submission documents are broken down into smaller components, prepared by multiple authors. This higher granularity, coupled with the need to provide extensive hyperlinking and cross-referencing for ease of navigation and review, has added significant process complexity.

Everyone from global multinationals to smaller biotechs has been forced to take a close look at their authoring and review processes. The smarter companies are realising the benefits of creating documents ‘with the end in mind’: empowering authors to create submission-ready documents right up-front, instead of relying on regulatory operations to mould them into shape later. Enter the world of document standards.

WHAT EXACTLY DO WE MEAN BY DOCUMENT STANDARDS?

Document standards consist of an author’s toolkit to facilitate efficient preparation of consistent, submission-ready documents across the organisation. Though the tools in that kit may vary according to specific needs, best practice encourages the inclusion of the following.