eCTD:Highlights and Updates
03 Jun 2017
he electronic common technical document or eCTD is an interface designed for the pharmaceutical industry to transfer regulatory information. This module-based regulatory application format was developed by the International Conference on Harmonization (ICH). In 2008, the United States Food and Drug Administration (FDA) made the eCTD format mandatory for all electronic submissions.
eCTD format is now widely used in the United States, Japan, the European Union and Canada.On May 5, 2015, the U.S. Food & Drug Administration published a final, binding guidance document requiring certain submissions in electronic (eCTD) format within 24 months. The projected date for mandatory electronic submissions is May 5, 2017 for New Drug Applications (NDAs), Biologic License Applications (BLAs), Abbreviated New Drug Applications (ANDAs) and Drug Master Files (DMFs). Till date, more than 600,000 eCTD sequences have been submitted to the FDA.
Lambda has expertise in preparing the dossiers that comply with the eCTD specifications. Dossiers go through a well-defined and streamlined work flow so that the final document is of utmost quality before submission to the regulatory bodies.
There are total 5 modules that a pharmaceutical company has to submit to the FDA.
- Module 1: Regional administrative information
- Module 2: Quality overall summary (includes Non-clinical overview, clinical overview, Non-clinical summary, Clinical summary)
- Module 3: Quality
- Module 4: Non-clinical study reports
- Module 5: Clinical study reports
Lambda has extensive experience in developing Module 5. We also help in preparing Module 2.4 (i.e. Non Clinical Overview), Module 2.5 (Clinical Overview) & Module 2.7 (Clinical Summary).
USFDA has released a guidance on the PDF specifications, Version 4.0, in September 2014. Reason for the revision is to align with the ICH recommendation on PDF. Major changes in Version 4.0 are with regards to the font type, font size, document navigation and maximum allowable PDF file size.
Some of the points that are taken care by Lambda (but not limited to) while dossier preparations are:
- PDF version should be 1.4
- All the documents should be text searchable.
- No security settings or password protection.
- Fully embed all non-standard fonts. Use font sizes ranging from 9 to 12 point. Times New Roman 12-point font is recommended for narrative text. Ten point fonts are recommended for footnotes.
- Page orientation for proper viewing and printing within the documents.
- Margins should be 0.75 on left side and at least 0.375 on the other three sidesUse of image should be avoided. Scanning should be done with minimum 300 dpi.
- Fast web view should be selected to reduce file sizes and file opening times.
- TOC should be prepared in case of files having 5 or more pages. Bookmarks and TOC should go together.
- When creating bookmarks and hyperlinks, the magnification setting must be set to “Inherit Zoom” so the destination page displays at the same magnification level used in the primary document.
- Initial view should be “Bookmarks Panel and Page”, and Page Layout & Magnification should be set to “Default.”
- Naming of PDF files should be in the lower case, avoiding special characters except hyphen and underscore.
- Maximum files size allowed by FDA is 100 MB, if there is any file which is exceeding the limit it needs to be split with clear TOC, Bookmark & Hyperlink