eCTD Guidance Document - eSubmission - Europa

Electronic media sets should be submitted at the same time as any required paper documentation.
The electronic media should be packed adequately to prevent damage and the package should
include a cover letter. Please see section 3.2.3 for details on the format of cover letters.
2.11 Archiving and working copies
Please refer to the Notice to Applicants, Volume 2A, Chapter 7 for details of the number of copies of
electronic submissions required for archiving and review purposes. Many NCAs destroy discs after
data has been uploaded into their systems. Where an NCA requires the disc to be archived they may
have additional requirements.. Note: The current standard to burn CDs / DVDs is UDF, which has
replaced the former ISO standard 9660.
2.12 Technical baseline applications
These should normally be submitted as sequence 0000. It should be clearly stated in the cover letter of
the “baseline eCTD” that the content of the current dossier has not been changed, only its format.
Consequently the first variation in eCTD format should then be submitted as sequence 0001. It is not
necessary for the baseline eCTD to contain document hyperlinks as it would not normally be
assessed.
The technical baseline application can also be used by applicants to switch from one eCTD sequence
per strength, to one eCTD sequence covering multiple strengths. For the switch the pros and cons of
the different approaches to dossier structure, as described in Annex 3, Table 1, should be taken into
consideration. The switch from one approach to another should only be allowed once during the life
cycle.
Guidance for Industry on Providing Regulatory Information in Electronic Format: eCTD Applications
Version: 1.0 May 2009
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