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

Submission Tracking and Notifications

Page standards status: Informative

Use case 2 of 3

Submission Tracking and Notifications

A consumer can follow a FedEx or Amazon package from “ordered” to “delivered” and get a notification at every step. RWI-pharma gives every party the same visibility into a regulatory interaction: each milestone is a Task status change, and each change is pushed to subscribers the moment it happens.

📦 Package delivery
Order placed
→
Shipped
→
In transit
→
Out for delivery
→
Delivered
📋 Regulatory interaction
Submitted
requested
→
Received
received
→
Validated
accepted
→
Under review
in-progress
→
Decision
completed
🏷️ Tracking number

The Task and its groupIdentifier identify the interaction and every related Task in the procedure.

🔔 Push notifications

A Subscription delivers each status change to the subscriber’s endpoint instantly — no portal log-ins, no polling.

🕓 Delivery history

Every Task version is timestamped, so the full history can be replayed as a timeline or rolled up into dashboards.

Examples

Because every milestone is a timestamped, machine-readable event, the raw exchange data can be turned into decision-ready views with no manual data entry. Both examples below are built from the same underlying Task history.

Scenario Example 1 · Real-Time Status Tracking & Notifications
Single-Procedure Lifecycle Timeline (Shelf-Life Update Test Scenario)

This is the "FedEx tracking view" of one procedure at full fidelity. The timeline below is derived entirely from the timestamped Task versions of the shelf-life update test scenario (procedure NDA-214365-S-021): a terminally rejected first submission, filing review and user-fee clearance, two Information-Request clock stops (RTQ XML), and the closing approval. Hover over any bar or milestone to see the underlying Task ids and status transitions.

Shelf-Life Update (24 → 36 Months) — Procedure Timeline Reconstructed from timestamped Tasks · groupIdentifier NDA-214365-S-021 · Day 0 = 03 Aug 2026 · Approved 03 Jun 2027 · 304 days total, 49 days in clock stops Procedure active (regulator / exchange)Clock stop — awaiting applicant response✕ Terminal validation failureMilestone✓ Approved Aug 2026 Sep Oct Nov Dec Jan 2027 Feb Mar Apr May Jun SUBMISSION & TECHNICAL VALIDATION Attempt 1 (eCTD 0045) — rejected, terminal Attempt 1 (eCTD 0045) — rejected, terminal — 03 Aug 2026. submit-shelf-life-update attempt 1, Task 3e74ce8e… v1 requested -> v2 rejected / validation-failed (terminal). Output: validation failure report (XML)✕03 Aug · same day Attempt 2 (eCTD 0046) — received & acknowledged Attempt 2 (eCTD 0046) — received & acknowledged — 03 Aug 2026. New parent Task 7f463290… v1 requested -> v2 received / submission-received; acknowledge-receipt completed same day03 Aug · same day FILING & USER FEE Filing review Filing review — 04 Aug 2026 → 02 Oct 2026 (59d). screen-submission-for-filing fbfd7f40… ; parent -> accepted / filed-accepted-for-review04 Aug – 02 Oct · 59dFiled — accepted for review · 02 Oct User fee — assessed · invoiced · cleared User fee — assessed · invoiced · cleared — 05 Aug 2026 → 13 Aug 2026 (8d). assess-user-fee, issue-user-fee-invoice, confirm-user-fee-payment -> fee-cleared05 Aug – 13 Aug · 8d ASSESSMENT Day 74 communication Day 74 communication — 16 Oct 2026. issue-day-74-communication completed / day-74-communication-issued16 Oct CMC & labeling assessment CMC & labeling assessment — 19 Oct 2026 → 14 Dec 2026 (56d). conduct-shelf-life-assessment in-progress / assessment-underway (inputs incl. ePI XML labels)19 Oct – 14 Dec · 56d Clock stop — IR 001 (RTQ XML) Clock stop — IR 001 (RTQ XML) — 14 Dec 2026 → 11 Jan 2027 (28d). respond-to-fda-ir-001: IR issued as RTQ XML, response received 11 Jan; assessment on-hold / awaiting-applicant-response14 Dec – 11 Jan · 28d IR 001 response review IR 001 response review — 12 Jan 2027 → 02 Feb 2027 (21d). conduct-shelf-life-assessment in-progress / response-under-review12 Jan – 02 Feb · 21d Clock stop — IR 002 (RTQ XML) Clock stop — IR 002 (RTQ XML) — 02 Feb 2027 → 23 Feb 2027 (21d). respond-to-fda-ir-002: IR issued as RTQ XML, response received 23 Feb; assessment on-hold / awaiting-applicant-response02 Feb – 23 Feb · 21d Response review & continued assessment Response review & continued assessment — 24 Feb 2027 → 03 May 2027 (68d). conduct-shelf-life-assessment -> completed / assessment-complete24 Feb – 03 May · 68dAssessment complete · 03 May DECISION Decision preparation Decision preparation — 04 May 2027 → 03 Jun 2027 (30d). prepare-regulatory-action in-progress / decision-preparation-underway04 May – 03 Jun · 30d Approval — parent Task closed Approval — parent Task closed — 03 Jun 2027. Approval letter + approved clean label (ePI XML); parent 7f463290… v9 completed / approved✓Approved · 03 Jun

The same feed rolls up across the whole portfolio, giving an applicant a live pipeline view of every procedure at every agency:

Active Portfolio — All Procedures, All Regulators

47
Active procedures
8
In clock stop
5
Decisions expected ≤ 30 days
23
Approvals year-to-date
Validation Under assessment Clock stop Decision phase
036912 Regulator A Regulator A: 2 procedures in validation 2 Regulator A: 6 procedures in under assessment 6 Regulator A: 2 procedures in clock stop 2 Regulator A: 1 procedure in decision phase 1 11 Regulator B Regulator B: 1 procedure in validation 1 Regulator B: 5 procedures in under assessment 5 Regulator B: 1 procedure in clock stop 1 Regulator B: 1 procedure in decision phase 1 8 Regulator C Regulator C: 1 procedure in validation 1 Regulator C: 7 procedures in under assessment 7 Regulator C: 3 procedures in clock stop 3 Regulator C: 1 procedure in decision phase 1 12 Regulator D Regulator D: 4 procedures in under assessment 4 Regulator D: 1 procedure in clock stop 1 Regulator D: 1 procedure in decision phase 1 6 Regulator E Regulator E: 2 procedures in validation 2 Regulator E: 6 procedures in under assessment 6 Regulator E: 1 procedure in clock stop 1 Regulator E: 1 procedure in decision phase 1 10
Procedures by current phase · rolled up live from Task.status / Task.businessStatus across every connected regulator · hover a segment for detail
Scenario Example 2 · Regulator Performance Dashboards
From the Same Data: Live Operations Board and Statutory Performance Reports

Regulators get the mirror image of the applicant's tracking view — for free. Because every procedure is an RWI-pharma Task with a full, timestamped status history, an agency can generate performance dashboards directly from its own exchange data: a real-time board of current activity, and aggregated quarterly or annual performance reports.

A — Live Activity Board (Flight-Board View)

A real-time view of everything currently in the house — like an airport departure board. Each status change anywhere in the agency updates the board instantly via the same subscription framework offered to applicants.

ACTIVE PROCEDURES — LIVE
auto-refreshed by subscription notifications · last event 14:32:07 UTC
PROCEDURE PRODUCT TYPE CURRENT PHASE DAY STATUS
SUB-2027-1204 Dermacort 1% cream Type IA Variation Submission received 0 ● RECEIVED
VAR-IB-2027-118 Cardizal 5 mg Type IB Variation Technical validation 2 ● VALIDATION
MAA-2027-0057 Virestat 200 mg Initial MAA Filing review 12 ● IN REVIEW
MAA-2027-0042 Oncomab 50 mg Initial MAA CMC assessment 142 ● IN REVIEW
NDA-214365-S-021 Stelbatolol 10 mg Supplement (shelf-life) Awaiting applicant response (IR 001) 133 ❚❚ CLOCK STOP
REN-2027-031 Neurofen XR 75 mg Renewal Decision preparation 55 ◆ DECISION DUE
VAR-II-2026-889 Oncomab 50 mg Type II Variation Closed 201 ✓ APPROVED

Every row is a parent RWI-pharma Task; the CURRENT PHASE column is Task.businessStatus and the STATUS column is Task.status. A task-update subscription notification flips the row the moment an assessor changes the Task — no polling, no data entry. Note the shelf-life test scenario (NDA-214365-S-021) sitting in its first clock stop, exactly as shown on the timeline in Scenario Example 1.

B — Quarterly & Annual Performance Reports

The same event history, aggregated over a reporting period, produces the statutory performance metrics that agencies publish today through manual compilation — outcome counts, average review times by procedure type, and bottleneck analysis. With RWI-pharma these are a query, not a project.

Median time to approval — the headline figure of a regulator’s annual performance report (e.g., a PDUFA-style report to Congress or an EMA annual report), computed directly from Task timestamps instead of manual compilation:

Median Time to Application Approval (Months)

Priority Standard
8.0
12.0
2021
7.9
11.5
2022
7.8
13.0
2023
7.7
12.2
2024
7.9
10.9
2025
Fiscal Year of Approval · computed from Task.authoredOn → Task.lastModified (approved)

First-cycle approval rate — the quality-of-review metric regulators publish each year, derived from the Task status history (was the application approved without a resubmission cycle?):

Percent of Applications Approved on the First Cycle

Priority Standard
50% 60% 70% 80% 90% 2021 2022 2023 2024 2025 Standard · FY 2021: 62% approved on first cycle Standard · FY 2022: 58% approved on first cycle Standard · FY 2023: 65% approved on first cycle Standard · FY 2024: 68% approved on first cycle Standard · FY 2025: 66% approved on first cycle Priority · FY 2021: 85% approved on first cycle Priority · FY 2022: 82% approved on first cycle Priority · FY 2023: 88% approved on first cycle Priority · FY 2024: 80% approved on first cycle Priority · FY 2025: 84% approved on first cycle 85% 84% Priority 62% 66% Standard
Fiscal Year of Application Receipt · first-cycle = approved without a resubmission cycle · hover a point for the value

Bottleneck detection — where does the time actually go?

Average Days per Phase

Regulator clock Applicant clock
0255075 Technical validation Technical validation: 12 days on average 12d Scientific assessment Scientific assessment: 75 days on average 75d Clock stop — awaiting applicant Clock stop — awaiting applicant: 45 days on average 45d Response review Response review: 21 days on average 21d Decision preparation Decision preparation: 10 days on average 10d
Average across procedures closed in the last 12 months · days · clock-stop time is applicant time, not regulator time
ℹ️ Note: For a step-by-step technical walkthrough of this use case, visit the Workflow page.