electronic Common Technical Document (eCTD)
The electronic common technical document (eCTD) allows for the electronic submission of the Common Technical Document (CTD) from the applicant to the regulator. While the table of content is consistent with the harmonized CTD, the eCTD also provides a harmonized technical solution to implementing the CTD electronically.
The specification is based on the Common Technical Document (CTD) format and was developed by the International Council for Harmonization (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG). Version 2.0 of eCTD, an upgrade over the original CTD was finalized on February 12, 2002, and version 3.0 was finalized on October 8 of the same year. As of August 2016, the most current version is 3.2.2, released in July 2008.
Specifications of eCTD
The specifications describe the way the files should be constructed for inclusion in the eCTD. The commonly used formats in the electronic submission are as follows, any other formats could be used according to the guidance published in each region.
1. PDF: Portable Document Format (PDF) is a published format compliant with the International Organization for Standardization (ISO) standard ISO 32000-1: 2008. The files must not contain JavaScript, dynamic content (e.g., audio, video or special effects), attachments or 3D content. Current versions of PDF recommended by the ICH website must be referred. The size of the file must on exceed 500 MB.
2. XML Files: The working group at the World Wide Web Consortium (W3C) developed the Extensible Markup Language (XML). It is a non-proprietary language developed to improve on previous markup languages. XML is currently used for some content of the eCTD.
Study Dataset Files
Specific regions include; study datasets and may have different rules regarding the following topics:
- Allowable file formats, Dataset files sizes,
- Dataset filenames and allowable characters.
eCTD submissions are accepted for the following applications:
- Investigational New Drug (INDs),
- New Drug Applications (NDAs),
- Abbreviated New Drug Applications (ANDAs),
- Biologics License Application (BLAs),
- All the master files are part of any above-mentioned applications.
Benefits of eCTD
- Improved handling and archiving of submissions.
- Better management of information.
- Support of life cycle management.
- Immediate access to complete and up to date information.
- Increased tracking ability.
- Facilitated evaluation and better visibility of the process.
- Reduced workload and reuse of information for assessment reports.
- Reduced external interference and proper communication.
- Good utilization of resources.
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