API for the Exchange of Medicinal Product Information (APIX)
0.1.0 - ci-build International flag

API for the Exchange of Medicinal Product Information (APIX), 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

Use Cases

Page standards status: Informative

Use Cases

APIX replaces today's fragmented, procedure-specific exchange mechanisms with a single, unified API doorway for everything.

🏆 The Decisive Advantage

Once a regulator or company implements APIX, they gain the ability to receive, process, and exchange every regulatory interaction — across all product types (drugs, biologics, devices, veterinary) and all procedures — through the same single API interface.

Priority Use Cases

1. Universal Regulatory Interface

Exchanging all regulatory activities for all products through a common standard.

THE PROBLEM

Fragmented channels and proprietary systems for different product types increase complexity and costs.

THE SOLUTION

A single, common way to exchange any regulatory activity for any product based on open web standards.

THE BENEFIT

One platform, one interface, one standard for every regulated interaction across the entire lifecycle.

2. Zero-Touch Lifecycle Management

Eliminating the manual burden of high-volume variations.

THE PROBLEM

Thousands of minor changes (Type IA/IB) consume vast resources in manual data entry and portal uploads.

THE SOLUTION

Machine-to-machine exchange. RIM systems auto-compile and submit; regulators auto-validate and accept.

THE BENEFIT

−80% reduction in submission preparation time. Zero increase in admin staff for massive volume growth.

3. Synchronous Regulatory Q&A

Ending the "Black Box" of communication delays.

THE PROBLEM

Information Requests arrive via email or static letters. Delays are invisible until deadlines are missed.

THE SOLUTION

Questions arrive as actionable FHIR Tasks directly into workflow systems. Responses route back instantly via API.

THE BENEFIT

−30% reduction in total "Clock Stop" duration. Full transparency for both sides.

4. Real-Time Dashboard (FedEx-Style Tracking)

Complete visibility across the portfolio.

THE PROBLEM

Companies lack real-time visibility into where their submission sits in the agency's queue.

THE SOLUTION

Unified status API. Every milestone triggers a real-time update visible in the company's dashboard.

THE BENEFIT

−95% reduction in "where is my submission?" admin inquiries. Predictable product launches.

Scenario Examples

Because every regulatory milestone in APIX is a timestamped, machine-readable event (see Real-Time Subscriptions), the raw exchange data can be transformed into decision-ready visuals with no manual data entry. The worked examples below are all reconstructed from the same underlying Task history.

Scenario Example 1 · Use Case 4 — Real-Time Dashboard (FedEx-Style Tracking)
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 APIX 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 APIX 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 APIX 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 these use cases, visit the Workflow Overview or the Workflow Deep-Dive.