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
How It Works
This page explains what a regulatory question and its response actually look like, section by section, using the same format as the interactive examples. It is written for a business audience and does not require any technical knowledge of FHIR.
Part 1: The Regulatory Question
When a health authority has questions about a regulatory submission, it sends a structured Question Set to the Marketing Authorization Holder (MAH). The diagram below shows exactly what that message contains.
B — Cover Letter
Please find enclosed the List of Questions regarding the Type II variation for ExampleDrug 10 mg Tablets. Responses are required by the due date above. Please ensure all answers reference the relevant CTD section.
C — Sender & Recipient
SENDER (REGULATOR)
National Regulatory Authority
regulatory.contact@example-nra.example.org
→
RECIPIENT (MAH)
SynthPharma AG
john.doe@synthpharma.example
D — Individual Questions
CTD: 3.2.P.8.1 Stability
Q-001
Are there any new stability studies included, or only additional timepoints?
Include protocol deviations if applicable. Reference: ICH Q1A(R2).
📎 Attachment: optional — e.g., reference document
+ additional questions follow the same structure...
A
Question Set Metadata
Every question set has a unique ID, a version number, the date it was issued, and a response due date. The procedure type (e.g. Type II Variation) is also captured here, so the recipient's system can automatically route it to the right team.
B
Cover Letter
A free-text area carries the narrative content that would traditionally appear in a cover letter — context, instructions, and any overarching comments about the question set. Rich formatting (bold, lists, tables) is fully supported.
C
Sender & Recipient
The issuing health authority (Sender) and the MAH or applicant (Recipient) are both identified with their name, contact details, and unique organisational identifiers. This enables fully automated routing without manual address look-up.
D
Individual Questions
Each question is a self-contained unit carrying: a unique reference ID, a CTD section tag (e.g. 3.2.P.8.1 — Stability) for automatic classification, the full question text with rich formatting, and an optional attachment (e.g. a reference document or data table). Multiple questions are grouped within a single Question Set.
Part 2: The Response
Once the MAH has prepared their answers, they send back a structured Response that maps directly back to each question in the original Question Set. The diagram below shows exactly what that response contains.
A — Response Metadata
Response ID: ID001-R | Status: Completed
Submitted: 2025-11-18 | Linked to: Question Set ID001
B — Response Cover Letter
Please find enclosed SynthPharma AG's responses to the List of Questions (ID001). All responses are provided in full, with supporting documentation attached where applicable.
C — Sender & Recipient
SENDER (MAH)
SynthPharma AG
john.doe@synthpharma.example
→
RECIPIENT (REGULATOR)
National Regulatory Authority
regulatory.contact@example-nra.example.org
D — Answers
Q-001
Are there any new stability studies included, or only additional timepoints?
Response
The submission includes both extended long-term data and new studies for pilot batches in the new packaging. No protocol deviations occurred.
📎 Stability_Summary_Report.pdf 📊 Stability_Data_Tables.xlsx
+ all other questions are answered in the same format...
A
Response Metadata
The response carries its own unique ID and submission date, and is explicitly linked back to the original Question Set ID. The status (e.g. Completed) lets the receiving system know the response is final.
B
Response Cover Letter
Just like the question, the response includes a free-text cover letter for any overarching narrative — introductory remarks, caveats, or cross-references — before the individual answers begin.
C
Sender & Recipient
The roles are now reversed — the MAH is the Sender and the Regulator is the Recipient. Both parties are fully identified, enabling automatic acknowledgement and filing at the receiving end.
D
Answers
Each answer is linked directly to its original question by ID, so there is never any ambiguity. The answer text supports rich formatting, and supporting documents (PDFs, spreadsheets, images) can be attached directly to each individual answer.