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

Universal Submissions

Page standards status: Informative

Use case 1 of 3

Universal Submissions

Every regulatory interaction uses the same building blocks: files are uploaded as Binary, described with DocumentReference, and orchestrated by a Task. Only the Task type and its documents change from one interaction to the next — not the channel, the portal, or the integration.

Post-approval change
Shelf-Life Update
Today: The variation dossier is compiled and uploaded to a procedure-specific portal or gateway; status is chased by email.
With RWI-pharma
  1. Applicant uploads the stability data and updated labelling as Binary + DocumentReference.
  2. Applicant posts a Task (e.g., supplement) that references the documents in Task.input.
  3. Regulator validates and reviews, raising questions if needed.
  4. Regulator completes the Task and attaches the decision letter to Task.output.
Safety reporting
ICSR Submission
Today: Individual case safety reports travel through dedicated safety gateways, separate from every other regulatory channel.
With RWI-pharma
  1. Applicant uploads the ICSR (e.g., ICH E2B(R3) XML) as Binary + DocumentReference.
  2. Applicant posts a Task for the case report that references it.
  3. Regulator acknowledges receipt by updating the Task and attaching the acknowledgment to Task.output.
  4. Follow-up reports for the same case are linked to the original case Task.
Product information
Label Negotiation
Today: Draft labels go back and forth as email attachments, and version control depends on file names.
With RWI-pharma
  1. Applicant submits the proposed labelling as an annotated ePI (tracked changes) and a clean ePI.
  2. Regulator posts a labelling-comments Task, with its own tracked changes on the ePI as input.
  3. Applicant accepts or counter-proposes in Task.output. Each round is a new Task, so every proposal and counter-proposal is timestamped.
  4. The agreed ePI is attached to the final decision as the approved labelling.
Requests & responses
Health Authority Question & Response
Today: Information requests arrive by email or letter, and clock stops and deadlines are tracked by hand.
With RWI-pharma
  1. Regulator posts a question Task (e.g., information-request) with the questions as input.
  2. Applicant is notified instantly and posts the response in Task.output.
  3. Regulator reviews the response and completes the question Task; the clock restarts.
ℹ️ Note: For a step-by-step technical walkthrough of this use case, visit the Workflow page.