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The Electronic Common Technical Document

Learn how XML is put to use in one part of the medical field, and how it's saving companies time and money. By Peter Aitken
The Electronic Common Technical DocumentThe XML specification--or recommendation, as is it is officially called--continues to show its power and flexibility, as more and more industries develop their own specialized XML languages for information processing. In the pharmaceutical industry, the electronic common technical documents, or eCTD, has been under development for several years, and is now starting to see widespread use.

The eCTD was designed for one specific purpose: the transmittal of information from the pharmaceutical industry to government regulatory agencies. Some background will help to provide perspective.

eCTD Background
Before a drug can be approved for sale, the company behind it must prove that the drug is both safe and effective, to the satisfaction of the controlling agency -- the Food and Drug Administration (FDA) in the US; European countries and Japan have their own corresponding agencies. This can be a mammoth undertaking that requires years of research and development. The final submission is huge, typically consisting of many tens if not hundreds of thousands of pages of documents that detail the animal tests, human clinical trials, manufacturing processes, and many other evaluations that are required by the regulatory agency.

While the three regions (US, Europe, and Japan) required similar information to evaluate a new drug, they had widely different requirements for the organization and presentation of this information. To deal with this and other inefficiencies in the drug registration process, industry and governments cooperated in forming the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, or ICH for short.

One ICH goal was to standardize the documentation requirements so that a pharmaceutical company could, with only relatively minor adjustments, submit the same application to the regulatory agencies in the three regions. The result was the Common Technical Document specification, or CTD, which has been widely adopted.

Don't let the term "document" fool you. A lot of us are used to thinking of a document as a single file, such as a Microsoft Word document or an Adobe PDF document. In contrast, a CTD submission consists or dozens or hundreds of individual files.

The CTD specification deals with the content and organization of the documents and says nothing about how they are submitted. A fully CTD-compliant submission can be, and often was, printed in its myriad copies and delivered by truck to the regulatory agency. Some rudimentary forms of electronic submission are in use, but they consist only of sending electronic copies of the documents instead of paper copies. The many potential advantages of an organized and standardized electronic submission format remained unrealized. The eCTD was developed in response to this need.

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Related Keywords:xml, ectd, pharmaceutical, medical, fda, drug, regulation, documentation, dtd


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