CRED Practical Document Writing and Management

Dealing with historical documents

Paper to eCTD: - ● Can be done at the start of any regulatory activity such as an extension, a renewal or a variation, ideally when no other regulatory activities are on-going for that product in another format. ● A baseline submission is recommended to change to eCTD - a compiled submission of the current status of the dossier, i.e. resubmission of currently valid documents that have already been provided to an agency – typically consist of Module 3 – let the agency know – include “baseline eCTD sequence” in cover letter – Always a separate submission and should never include new applications. The first new regulatory activity, e.g. the next variation, in eCTD format should then be submitted as sequence 0001 – Example of a typical baseline:-