Regulatory Workflows and Interactions - pharma
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Regulatory Workflows and Interactions - pharma, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/APIX---API-Exchange-for-Medicinal-Products/ and changes regularly. See the Directory of published versions

Automation

Page standards status: Informative

Use case 3 of 3

Automation

Because every question and response arrives as a structured, machine-readable Task, the receiving system can act on it the moment it arrives. Nobody has to watch an inbox and decide where each message should go.

Receiving a question
Route questions automatically on receipt
1The regulator posts a question Task with the questions attached.
2The applicant’s system is notified instantly through its Subscription.
3Routing rules read the Task — its type, the product, and the CTD sections of the referenced documents.
4The question lands in the right team’s queue (for example CMC, labelling, clinical, or safety), with the response due date taken from the Task.
Receiving a response
Route responses automatically on receipt
1The applicant adds its response to the question Task’s Task.output.
2The regulator’s system is notified instantly through its Subscription.
3The response is matched to the original question and procedure through the Task’s identifiers.
4It is routed straight to the reviewer who asked (Task.requester), and the clock restarts.
✓ No manual triage ✓ No missed deadlines ✓ Clock stops start and end on their own
ℹ️ Note: For a step-by-step technical walkthrough of this use case, visit the Workflow page.