Response to Regulatory Questions (RTQ)
0.1.0 - ci-build

Response to Regulatory Questions (RTQ), published by HL7 International. 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/rtq-ig/ and changes regularly. See the Directory of published versions

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Official URL: https://build.fhir.org/ig/HL7/rtq-ig/ImplementationGuide/hl7.fhir.uv.rtq-ig Version: 0.1.0
Draft as of 2025-12-09 Computable Name: RTQ_IG

Introduction

The Response to Question (RTQ) Implementation Guide is the standardized framework for the structured, algorithmic exchange of regulatory questions and responses. Built on HL7 FHIR R5, it replaces static Word and PDF documents with traceable, machine-readable resources—enabling precise tracking, automated triage, and global harmonization.

This guide defines the technical framework to create a seamless Q&A loop between Regulators and Applicants.

Why Adopt RTQ?

  1. Structured & Traceable Every question is a discrete Questionnaire item; every answer is a linked QuestionnaireResponse. No more lost questions or ambiguous email threads.

  2. Harmonized Across Agencies One standard format for FDA, EMA, PMDA, and other health authorities. Build your system once to handle questions from any regulator.

  3. Analytics-Ready Because questions are structured data, you can instantly visualize trends: response cycle times, most frequent question topics, and regional variances.

  4. Automated Workflow APIs can automatically route questions to the correct Subject Matter Expert (SME) based on metadata (e.g., "Quality", "Clinical"), reducing triage time from days to minutes.

Background

In biopharmaceutical regulatory affairs, health authorities routinely issue formal questions during the review of marketing authorization applications. Traditionally, these are exchanged as unstructured Word or PDF documents via email or portals. This results in high manual effort, limited traceability, and "dead data" that cannot be analyzed.

RTQ changes that by modeling questions as reusable Questionnaires and responses as versioned QuestionnaireResponses, aligning regulatory Q&A with the modern digital ecosystem of healthcare.

This aligns with the broader strategy defined in the APIX Implementation Guide: moving towards the "Real-time algorithmic exchange" envisioned in the 2023 International Journal of Pharmaceutics framework (click to read).

Just as ISO 20022 harmonized global payments, RTQ + APIX harmonizes the regulatory dialogue—standardizing the content (RTQ) and the exchange (APIX) to unlock sub-second decision making.

In Scope

  • Health Authority Questions: Profiling of Questionnaire for widely used regulatory templates (Validation issues, Major Objections, Request for Information).
  • Sponsor Responses: Profiling of QuestionnaireResponse for applicant replies, supporting evidence attachments, and cross-references.
  • Regulatory Metadata: Standardized extensions for due dates, severity, and review status.

Out of Scope

  • The full submission packaging and transport layer (see the APIX Implementation Guide for instructions on how to package and transport the questionnaire and questionnaire response).

Governance & Collaboration

RTQ is developed under the HL7's Biomedical Research and Regulation (BR&R) Working Group with active participation from regulators, pharmaceutical companies, and technology vendors.

All meetings are public; notes and recordings are available via HL7 BR&R Working Group's RTQ project page.

Get Involved

  • Join the weekly calls.
  • Test the reference implementation.

We welcome industry, solution providers, and regulators from every region to contribute to this global standard.