Frequently Asked Question on eCTD ( Electronic Common Technical Document)
What are the specification for eCTD?
Do we need to Learn XML for preparing eCTD?
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Common Technical Document(CTD) is an industry standard document in Pharmaceutical industry adopted by US, EU, Canada and Japan for regulatory submission. eCTD is an electronic version of CTD.
eCTD is an interface for Pharmaceutical industry to agency transfer of regulatory information. Here eCTD is not limited to transfer of information it also considers creation, review, life cycle management and archival of electronic submission. It facilitates paperless submission to the respective authorities.
Contents of eCTD
- XML
- Folder Structure
- DTD
- STF
- PDF or Portable Documents
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What are the specification for eCTD?
Specification for eCTD are as follows
- ICH eCTD Specification v3.2 ( Souce : FDA Website)
- EU Module 1 Specification v1.3 (Source : eSubmission EMEA )
- US Module 1 Specification Updated (12/13/06) ( Source : FDA Website)
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There is no deadline set to make eCTD mandatory by law, rather it will be more of a de facto.
- 1st uly 2008 EMEA accepts Electronic Only submission either in eCTD or Non-eCTD format,with no additional requirement for Paper Copies. (eCTD Recommended)
- 1st January 2009, EMEA will strongly recommend electronic only submission.
- 1st July 2009 EMEA will strongly recommend eCTD format electronic only submission.
Reference : EMEA Implementation of Electronic Only Submission and e-CTD
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An Publishing system or an ectd publishing software creates eCTD directory and populates the same with pdf files , it creates the XML backbone automatically as required for eCTD.
There are many publishing software’s available in the market, which will help in preparation of CTD in eCTD format.
Publishing Software + Document Management Software is an ideal combination for complete eCTD solution.
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XML i.e. Extended Markup Language is a markup language similar to HTML, it allows users to define their own elements. The primary purpose of XML is to carry data.
XML is recommended by W3C
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Document Management System is a computer system used to store and track electronic documents, images of documents. It helps control version of documents by check in and checkout functionality. This feature enables only one person working on the said file any given time there by removing multiple versions. It also has an audit trail to review who has checked in and out a file and when.
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MD 5 Message-Digest algorithm 5 is used for wide variety of security application. It is also used to check the integrity of the file.
In eCTD MD5 Checksum is used to see if the file content has not been tampered.
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PDF- Portable Document Format is a file format created by Adobe Systems INC in 1993 to exchange documents. Files in PDF format can be viewed by anybody on any computer. Software required to see these files is called “Adobe Reader” distributed free of cost by Adobe Systems Inc.
In regards to eCTD ICH specification for PDF files can be found below.
PDF Specification (6/4/2008) Source (FDA Website)
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Do we need to Learn XML for preparing eCTD?
No, there is NO Need to Learn XML for preparing eCTD,but some knowledge of XML can be beneficial.
Publishing softwares pepare XML backbone of eCTD by using information from the user. There is no programming or coding of XML here.
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If your have an question that is not listed here, email us your Queries NOW for an 48 hours response.
Email Us info@perfect-consultants.com gupta1@vsnl.com
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