CRED Practical Document Writing and Management

Dealing with historical documents

NeeS to eCTD: - ● Submit new data in eCTD format starting the lifecycle in accordance with eCTD specifications. ● The first submission in eCTD format will normally be sequence 0000, even if sequential numbers were used for the NeeS format. ● As documents already exist in an electronic format, re-send the currently valid documents, especially module 3, as a baseline eCTD dossier in sequence number 0000 and then the first new regulatory activity as 0001. ● A baseline can also be submitted later in the lifecycle. If documents have already been provided in previous submissions in the sections now covered by the baseline, these should not be re-submitted. Instead, the remaining incomplete sections should be filled up with earlier dossier content (paper or NeeS), now provided in eCTD format for the first time.

NeeS folder structure