Editing Regulatory Information for a Submission

You can edit many of the fields on the Regulatory Information page tab for a submission.

Required access roles: Submission Lead on the submission project with Regulatory Lead or Regulatory User role, or submission project owner

You can edit these properties until the Market Authorization milestone is complete. If the submission project is beyond the Draft state, you must add a justification for your edits.

  1. View the Regulatory Information page tab for a submission. See Regulatory Information Properties Page.
  2. In the page Actions menu or toolbar, click Edit .
  3. Edit these details as needed:

    SectionField NameDescription
    TitleA descriptive title for the submission.
    Registration FeeThe fee paid to theregulatory authority for processing the submission.
    Authority Application NumberThe application number assigned when the regulatory authority receives the regulatory authority. This number should be used on all subsequent correspondence.

    You can edit this field only until the milestone for Dossier Submitted is complete.

    Publishing File FormatThe file format required by the regulatory authority:
    • eCopy: The electronic submission is an exact duplicate of the paper-based submission. (You must select this format to see the Publishing category for a submission.)
    • eCTD: The electronic submission content is based on the Common Technical Document (CTD) format.
    • NeeS: The electronic submission is in a non-eCTD format.
    • Paper-based: The submission is paper-based.

    You can edit this field only until the milestone for Dossier Submitted is complete.

    Regulatory Activity CategoryThe regulatory activity category defined for this submission.

    You can edit this field only until the milestone for Dossier Submitted is complete.

    Regulatory Activity Sub CategoryThe subcategory for the activity category.

    You can edit this field only until the milestone for Dossier Submitted is complete.

    Follows Leading CountryIndicates whether the countries associated with this submission project follow the regulatory lead of another country.

    You can only use leading countries for the first Initial Submission (that is, not an Initial Submission created from a submission master record).

    Possible ValueDescription
    As DefinedThe defined leading/following countries relationship is used, and the Leading Country field shows the name of the lead country.
    Not RequiredAny defined leading/following countries relationship is not used, and the Leading country field is blank and cannot be edited.

    If you choose this value, any country listed in the Leading Country field is erased.

    With DeviationThe normal leading/following countries relationship is not used, but the country for the context submission will follow another country. The Regulatory Lead must select a leading country.

    Leading CountryClick to select the country that all of the countries associated with the submission project follow for regulatory affairs.

    You can only use leading countries for the first Initial Submission (that is, not an Initial Submission created from a submission master record).

    Reason for ChangeJustification for changes made to the regulatory information for a submission after it is started. See Justifying Changes to Submissions.
    StatusDossier SubmittedThe type of submission evaluation:
    • Evaluation
    • Referral
    • Appeal

    Regulatory Request Responders take this dossier evaluation type into consideration when preparing documents.

    You can edit this field only until the milestone for Dossier Submitted is complete.

    ResultsThe overall result of the submission. This column is blank until the results are entered.

    How the regulatory authority ruled on the submission:

    • Approved
    • Rejected
    • Withdrawn

    You can edit this field prior to completing the submission.

    NotesAny notes entered for this submission project.
    Wave ReferenceOnly shows if the submission type is Initial Submission.

    The wave reference for a submission that uses the Mutual Recognition Procedure (MRP).

    If you derive a submission project from this one, you need to manually edit this value.

  4. Click Done.