Be Prepared: Document management for the uninitiated – Part 1

| by John Farrell

The push to conduct clinical trials and bring products to market in the EU often catches companies with limited marketed product experience off-guard.

As they progress through the clinical development phases, they develop a large library of completed and approved documents which comprise their dossier. There is an assumption that this emerging monument to effort will be immutable and that from here on in it is a case of  simply adding further to it.

However, it’s never that simple, especially in the largest pharmaceutical markets, including the EU, the United States, and other global markets with similar regulatory requirements, such as Japan, Canada and Australia.

In the early stages of development, documents are for the most part linear, that is to say they are developed through their natural life cycles, approved and then held as final versions. However, as development progresses, more and more summary documents are created, and, as a result, the approved version is revisited and periodically updated. Documents such as the investigational medicinal product dossier (IMPD), the investigator’s brochure and even protocols evolve post initial approval so understanding who has what version of each document starts to become an issue.

As the product moves into approval, further documents are generated as updates are circulated to multiple third parties in a form that allows comparison to the last version received. Moreover, as the product moves into manufacture the manufacturing scale up process also gives rise to further changes to existing documents.

The Reality is that to successfully submit a product to regulatory authorities in the EU or US, companies need a solid document management backbone. This is crucial to ensuring every stakeholder – across clinical, regulatory, safety, CMC and commercial – can access and work on relevant elements of the document. Whether this is achieved with “manual controls” or through deployment of a fully-fledged DMS (or some compromise in between) is essentially irrelevant; however it is worth remembering that  in both the US and the EU, as well as several other major markets, all regulatory submissions must be made electronically through the electronic common technical document (eCTD), which pre-supposes the existence of well-defined IT and document management capabilities.

In the next two blogs, I will share my thoughts on what it means to Understand the eCTD challenge, and what the regulators expect in terms of submission processes. As you prepare to bring your products to market and gain approval from the European Medicines Agency, the Food and Drug Administration and other regulatory authorities, paying heed to standards, dossier structures and submission expectations will help you achieve the outcomes you are hoping for – product approval in the largest global markets.

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