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In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.
Version 2.0 of eCTD – an upgrade over the original CTD – was finalized on February 12, 2002, [1] and version 3.0 was finalized on October 8 of the same year. [2] As of August 2016, the most current version is 3.2.2, released on July 16, 2008. [3] A Draft Implementation Guide (DIG) for version 4.0 of eCTD was released in August 2012. [4]
Detailed subheadings for each module are specified for all jurisdictions. The contents of Module 1 and certain subheadings of others differ based on national requirements. However, investigational new drugs meant for emergency use or treatment applications and not for commercial distribution are not subject to the CTD requirements. [5] [6]
In 2000, Microsoft released an initial version of an XML-based format for Microsoft Excel, which was incorporated in Office XP. In 2002, a new file format for Microsoft Word followed. [ 9 ] The Excel and Word formats—known as the Microsoft Office XML formats —were later incorporated into the 2003 release of Microsoft Office.
The minimum essential documents that are required for the registration of pharmaceutical products designed for human use are specified in the document 'ICH Good Clinical Practices,' published in 1997 by the ICH [2] Example ICH essential documents that would be required in any US, EU or Japan based clinical trial would include: signed protocol ...
Besides differences in the schema, there are several other differences between the earlier Office XML schema formats and Office Open XML. Whereas the data in Office Open XML documents is stored in multiple parts and compressed in a ZIP file conforming to the Open Packaging Conventions, Microsoft Office XML formats are stored as plain single monolithic XML files (making them quite large ...
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Office Open XML (OOXML) format was introduced with Microsoft Office 2007 and became the default format of Microsoft Excel ever since. Excel-related file extensions of this format include:.xlsx – Excel workbook.xlsm – Excel macro-enabled workbook; same as xlsx but may contain macros and scripts.xltx – Excel template.xltm – Excel macro ...