Most Pharmaceutical companies are failing to produce, issue submissions and other necessary documents in the early stages of the clinical study process will emphatically confront delays in the submissions process and finally the drug companies suffer with delayed approval process, potentially losing their benefits as their products take very longer time to bring in to the market. This article takes a view how to avoid the common pitfalls that are involved while filing an electronic Common Technical Document (eCTD) by drug research sponsors.
What is an eCTD?
The acronym eCTD stands for “electronic common technical document”, developed by the “International Conference on Harmonization (ICH)”, Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG) in 2004.
Before the advent of the eCTD, a regulatory submission was constituted of a large paper document that used a table of contents (TOC). An electronic common technical document uses an XML a good choice submission tool serves as an electronic TOC, determining the overall structure of the submission.
Drug regulatory submissions are always been a challenge for the drug research players. In the past, large volumes of required regulatory documents, geographical standards made under regulatory submissions are used to take very long time and looks to be very costly practices.
The industry’s espousal of the electronic common technical document (eCTD) ameliorates the regulatory submission process, fastens the review process, shortens the time-to-market and reduces the costs involved. The Food and Drug Administration (FDA) authority set January 1, 2008 as the point in time to abide by with the new submission under standard electronic submissions.
How an eCTD format simplifies the process?
It consists of :
- An XML-based eCTD (backbone) substitutes separate PDF Table of Contents documents.
- The enhanced document graininess possible here in accordance with ICH eCTD agreements that help in easier and faster review.
- There is no requirement to submit technical sections in paper; the eCTD Viewer System executes a fixed substantiation of the lynchpin against the document type definition (DTD). The document type definition sets the legal building blocks of an XML document.
- The pharmaceutical sponsor can use Part 11-compliant electronic signatures in this submission.
Comparing Paper CTD and eCTD:
|Complied electronically with volumes, tabs and slip sheets, then printed to paper||Complied electronically with eDocument in folders|
|Paper volumes must be A4||edocuments‘ can be A4 or US letter Size|
|CTD navigation by TOCs and Volume||eCTD navigation by XML backbone|
|Cross-references includes target CTD section number||Cross-references are weblinked to targets|
|Manual document navigation by TOCs, page numbers and caption cross-references||Electronic document navigation by TOC’s, bookmarks and weblinks|
|Submitted in binders in boxes on pallets by trucks||Submitted on CD or DVD or by email|
Few Tips for successful electronic Common Technical Document Submission:
- Obtain thorough knowledge of Food and Drug administration’s standards
- Manage all information and communication flow
- Plan the eCTD before target submission date: Get the eCTD publisher onboard early; has authors work from standardized templates and style guides and Map out the data deliverables for the submission.
- Include table of contents in all PDF documents: For each document:
- if a paper document requires a TOC, a PDF documents will needs a web linked table of contents; No change from eNew Drug Application – be compelled both bookmarks and web links; Cross-document links still work in an eCTD.
- Ensure all PDF web links and bookmarks are correct:
- Make all valid or confirm validity of hyperlinks and bookmarks under file; Provide bookmarks with nonrational names.
- Test before you submit the file.
- All XML documents must use standard components
- UTIL Folder: there are 3 standard style sheets in the UTIL folder
- 3 standard document type definition (DTD) s and try to avoid GIFs, custom CSS, custom DTDs, and custom elements with standard DTDs.
- All documents should adapt to eCTD designated component system / always avoid “mixing” documents at a higher parent leaf level.
- Always do not use node extensions: Node extensions are unnecessary; the Food Drug and Administration and ICH do not recommend node extensions.
- Ensure that all number sequence is 4 digits:
- Sequence number is key and links all submission components together. It should n’t be alpha or special characters and No spaces.
- Ensure that all application numbers are 6 digits:
- No alpha characters, No spaces or special characters
- Include Module 1 in all eCTD submissions: Every electronic Common Technical Document submission requires Module 1, which identifies the following important information:
- Company name, Drug name, Submission type, Submission date, Application number and Sequence number.
- Correctly use all elements and leaf titles which mentioned under guideline
- Create QC steps into the review process.