The workflow enables the Regulatory Report Creator to specify the necessary attribute values for the type of regulatory submission. Upon completion, the Regulatory Report Approver reviews and approves the regulatory submission. The approved regulatory submission is then ready for transmission to the regulatory agency.

You can also use this workflow to update the attribute values as required by the regulatory agency.

You can edit and approve the regulatory submission through a Change Management or Promotion Request process. In this case, the corresponding workflow is used. The life cycle of the regulatory submission is designed to accommodate both the processes.

This workflow is designed to transmit a regulatory submission to a regulatory agency. This workflow generates the regulatory submission payload and the human-readable regulatory submission report. After these artifacts are attached to the regulatory submission, the regulatory submission payload is transmitted to the assigned regulatory agency using the configured communication method. The workflow then tracks the regulatory submission acknowledgement messages from the regulatory agency. These acknowledgement messages are processed based on the acknowledgement interpreter for the regulatory submission type. Regulatory submissions that require modifications are routed for rework with appropriate acknowledgement messages. Those that pass all the regulatory agency steps are processed for completion. All the acknowledgement messages are recorded as regulatory content and can be viewed in the Acknowledgement Messages table on the information page of the regulatory submission.

This workflow is designed to cancel a regulatory submission. The regulatory submission is processed for cancellation using the predefined API behavior. The cancellation event is then posted to enable other business objects respond to the cancellation of the regulatory submission.

This workflow is designed to execute a regulatory decision post customer experience evaluation and determine the reportability of the new decision. If complete information could not be provided while creating the regulatory decision, an additional assignment allows updating the regulatory decision. If the adverse event is reportable, this workflow automatically creates and processes the submission of the Adverse Event Report regulatory submission. Otherwise, the regulatory decision process closes.

This workflow is designed to re-evaluate the reporting duration, the reportability of the adverse event, and the supporting evidence for the regulatory decision after a reportable decision has already been made. If a reportable decision is re-evaluated as non-reportable, the evaluation task completes and the associated Adverse Event Report regulatory submission is mandatorily cancelled.

This workflow is designed to synchronize a regulatory decision with the transmission progress of the regulatory submission. This workflow monitors the following Regulatory Submission process events: