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

Response Structure

When a marketing authorization holder (MAH) receives a list of questions from a health authority (e.g., EMA, FDA, PMDA), they submit a structured, machine-readable response using the RTQ (Response to Regulatory Questions) FHIR profile.

This resource enables automated routing, tracking, and review management while preserving rich formatting, organizational context, and traceability to the Common Technical Document (CTD) structure.

Purpose & Business Value

  • Standardized Communication: Ensures consistent, unambiguous response format across sponsors and agencies
  • Automated Workflow: Enables integration with RIM systems, document management platforms, automation tools, and AI agents
  • Audit Trail: Full traceability of sender (MAH), recipient (authority), submission date, and coded categorization of each answer
  • Rich Text Support: Preserves bold, hyperlinks, tables, images, and formatting from standard authoring tools
  • Global Interoperability: Aligns with ICH, HL7 FHIR, and IDMP standards

HTML Presentation Example

The following is an HTML rendering of a FHIR QuestionnaireResponse:
Sample response from MAH to regulator

Key Elements of a Regulatory Response

Element Purpose Example
identifier Unique IDs for the response set and regulatory procedure ID001, EMEA/H/C/005432/II/0023
questionnaire Link to the original question set RegulatoryQA-ID001
authored Date and time the response was submitted 2025-11-15T14:59:00-05:00
contact (SENDER) MAH submitting the response with full organizational context SynthPharma AG, Dr. John Doe, Basel
contact (RECIPIENT) Health authority receiving the response EMA, Dr. Jane Doe, Amsterdam
item.linkId Matches the original question ID cmc-1-DP-Stability
item.code CTD section mapping (hierarchical) 3.2.P.8 → 3.2.P.8.1 Stability Summary
item.text The original question (shown exactly as received) “Are there any new stability studies conducted…?”
item.answer.value[x] The MAH's answer in rich text (XHTML) Includes bold, lists, tables, images, and references

Example Use Case: EMA Type II Variation

Scenario: MAH receives 10 questions on stability and labeling during review of a shelf-life extension.

With this profile:

  • Original questions are preserved exactly
  • Each answer maps to the same CTD section
  • Regulatory system auto-routes responses to reviewers
  • Submission date is tracked
  • Full audit trail from MAH to authority

How to Use This Profile

  • MAH (Sponsor): Import questions into RIM system; prepare answers; export as FHIR RTQ Response
  • Health Authority: Receive structured response; auto-match to original questions; route to reviewers
  • Vendors: Support structured authoring of answers and export to FHIR-compliant XML or JSON for submission via email, portal, or API
    Refer to APIX IG for details