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

Question Structure

The Regulatory Questionnaire profile defines a structured, machine-readable format for regulatory questions issued by a health authority (e.g., EMA, FDA) to a marketing authorization holder (MAH) during the review of a regulatory submission such as a Type II Variation, NDA, or MAA.

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

Purpose & Business Value

  • Standardized Communication: Eliminates ambiguity in question format across agencies and sponsors
  • Automated Workflow: Enables integration with structured authoring systems, regulatory information management systems, document management platforms, atuomation, and AI agents
  • Audit Trail: Full traceability of sender, recipient, deadlines, and coded categorization of each question
  • Rich Text Support: Preserves bold, hyperlinks, tables, images, and formatting from standard structured authoring tools
  • Global Interoperability: Aligns with ICH, HL7 FHIR, and IDMP standards

HTML presentation example

The following is a HTML rendering of a FHIR Questionnaire with synthetic Quality: Sample question from a regulator to a market authorization

Key Elements of a Regulatory Question

Element Purpose Example
identifier Unique IDs for the question set and regulatory procedure ID001, EMEA/H/C/005432/II/0023
title Human-readable summary of the question set Responses to Question Set ID001
effectivePeriod Deadline for sponsor response 2025-11-11 to 2025-12-11
contact (SENDER) Issuing health authority with full organizational context EMA, Dr. Jane Doe, Amsterdam HQ
contact (RECIPIENT) MAH responsible for response SynthPharma AG, Dr. John Doe, Basel
contact-signature extension Email-style signature block with name, title, org, and contact info Preserves official formatting
item.linkId Unique question identifier within the set cmc-1-DP-Stability
item.code CTD section mapping (hierarchical) 3.2.P.8 to 3.2.P.8.1 Stability Summary
item.text The regulatory question in rich text (XHTML) Includes bold, links, paragraphs, tables, images, and references

Example Use Case: EMA Type II Variation

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

With this profile:

  • Questions are machine-readable
  • Each maps to CTD section (e.g., 3.2.P.8.1)
  • Sponsor system auto-routes to CMC and labeling teams
  • Response deadline is enforced
  • Full audit trail from EMA to MAH

How to Use This Profile

  • Health Authority: Generate Questionnaire from review tool; include rich text and CTD codes
  • MAH (Sponsor): Import into RIM system; assign owners; link responses via QuestionnaireResponse
  • Vendors: Support structured authoring of the question and export to a FHIR-compliant XML or JSON file for submission via email or portal; or incorporate into a Task resource for submission via API Refer to APIX IG for details