eCTD Guidance Document - eSubmission - Europa

2.9.6 Other File Formats
Other file formats such as rich text (RTF) or MS Word formats may be required in addition to the PDF
requirement of the eCTD, by specific NCAs or the EMEA, especially for the provision of product
information documents or the Module 2 documents. Please refer to the Notice to Applicants, Volume
2A, Chapter 7 for further details.
These files should not be added as leaf elements within the eCTD
structure. They should be provided in a separate folder called,
e.g.“-workingdocuments” on the CD/DVD containing
the eCTD.
2.9.7 Technical validation of eCTD submissions
The technical validation of an eCTD is a separate activity to the content validation of a submission and
takes place irrespective of the type of the submission. NCAs and the EMEA have adopted a common
set of technical criteria against which all eCTDs can be checked using eCTD review and validation
tools.
The general process for the validation of eCTD submissions is divided into two parts: technical and
content validation. An eCTD must pass technical validation before it undergoes content validation.
Technical validation errors of category A will result in the applicant being asked to resubmit the eCTD
sequence with the same sequence number, category B errors will normally not require resubmission
but may require fixing in a subsequent sequence, category C do not require resubmission but may be
fixed in subsequent sequences at the applicant’s discretion.
Errors found during the content validation should be resolved through the submission of a new eCTD
sequence. These errors must never be resolved by resubmitting an existing sequence.
2.10 Other Technical Information
2.10.1 Security issues
The physical security of the submission during transportation is the responsibility of the applicant.
Once received by NCAs and the EMEA, security and submission integrity is the sole responsibility of
NCAs and the EMEA.
2.10.2 Password protection
Submission or file level security is not permitted. If one-time security settings or password protection of
electronic submissions are used this could constitute grounds for the rejection of the submission.
2.10.3 Virus protection
The applicant is responsible for checking the submission for viruses. Checking should be performed
with an up-to-date virus checker and be confirmed in the cover letter. After receipt at NCAs and the
Guidance for Industry on Providing Regulatory Information in Electronic Format: eCTD Applications
Version: 1.0 May 2009
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