eCTD submissions must be valid, and should facilitate the reviewing process by regulatory authorities. According to the FDA’s eCTD Digital Handbook, avoiding the following 10 frequent mistakes will:

  • Improve the quality of your submission.
  • Minimize the risk to get “Refuse to file” or “technical rejection” letters from the FDA, that typically delay the reviewing process from several weeks to several months.

Fortunately, Ennov Dossier helps you avoid most of these mistakes, saving you precious time in the submission and reviewing process.


1PDFs without table of contents

Table of contents are compulsory and essential for the reviewing process. They enable the reviewers to have a global view of the submission elements and considerably save time to reviewers. Moreover, table of contents need hyperlinks, which enable reviewers to swiftly navigate among the many documents of your submission.

eCTD 247 automatically generates table of contents and hyperlinks in the PDF files of your submission.


2PDFs with incorrect hyperlinks or bookmarks

Incorrect hyperlinks or bookmarks degrade the perception of quality of your review and waste the time of reviewers. All hyperlinks and bookmarks must be checked and correct.

eCTD 247 automatically validates all hyperlinks and bookmarks in the PDF files of your submission.


3Non standard DTDs, CSS or GIFs

The “UTIL” folder must contain the 3 standard DTDs and the standard CSS. If you modify or customize any of these elements, the reviewing process will be impaired.

eCTD 247 automatically inserts the correct DTDs and CSS in your submission.


4Document with incorrect granularity

Combining documents to decrease the number of documents of the submission impairs the reviewing process and ultimately complicates the life cycle of the submission.

eCTD 247 is able to automatically split your documents if you wish so, to comply with the specified granularity of the submission.


5Incorrect MD5 checksum

MD5 checksums provided included in the regional, index.xml and index-md5.txt files must be correct.

eCTD 247 automatically generates correct MD5 checksums.


6Node extensions

Node extensions are not accepted where the DTD does not allow for them, and some regulatory agencies do not accept them altogether.

eCTD 247 ensures that node extensions can be created only where the DTD allows it.


7Incorrect sequence number

Sequence numbers must be 4 digits, and should not contain letters, punctuation signs or spaces. They are an essential element of the submission, as they enable to analyse the history of the submission.

eCTD 247 automatically generates correct sequence numbers.


8Incorrect application number

Application numbers must be 6 digits, and should not contain letters, punctuation signs or spaces. The application number is essential, as it enables to relate several submissions as a common application.


9Submission without Module 1

Module 1 is indispensable as it provides essential information: company name, drug name, submission type and date, application and sequence numbers.

Once Module 1 is present, eCTD 247 checks the presence of the cover letter (which is compulsory) and that the countries of the envelope are the same.


10File not referenced in the XML backbone

Unreferenced files cannot be located by reviewers, which poses problems as the corresponding information can be considered as missing by reviewers.

eCTD 247 automatically references all files in the XML backbone. You will not have to edit XML files.


Of course, eCTD 247 performs many more validation checks to ensure the quality of your submission. Contact us to learn more about how we can streamline your eCTD submission process.

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