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

CodeSystem: RTQ Questionnaire Type Code System (Experimental)

Official URL: http://hl7.org/fhir/uv/rtq/CodeSystem/rtq-questionnaire-type-cs Version: 0.1.0
Draft as of 2025-11-21 Computable Name: RtqQuestionnaireTypeCS

Code system defining the high-level types of regulatory questionnaires exchanged between industry and health authorities.

This Code system is referenced in the content logical definition of the following value sets:

  • This CodeSystem is not used here; it may be used elsewhere (e.g. specifications and/or implementations that use this content)

This case-sensitive code system http://hl7.org/fhir/uv/rtq/CodeSystem/rtq-questionnaire-type-cs defines the following codes:

CodeDisplayDefinition
list-of-questions List of Questions A formal list of questions raised by a regulator requiring a written response from the marketing authorisation holder.
list-of-issues List of Issues A consolidated list of major and minor issues identified during assessment that must be resolved before approval or variation.
information-request Information Request A formal request for additional information or clarification during evaluation of a submission (e.g., EMA Day 120/180 LoQ, FDA IR, Health Canada Clarifax).
request-for-clarification Request for Clarification Request seeking clarification on specific points in a submission (often used by PMDA, Health Canada, Swissmedic).
request-for-supplementary-information Request for Supplementary Information Used by some regulators (e.g., Swissmedic RSI, Saudi SFDA) for additional data requests.
deficiency-letter Deficiency Letter Formal notification of deficiencies that must be addressed (common in some national procedures).
consolidated-list-of-questions Consolidated List of Questions A single consolidated set of questions from multiple assessment teams (e.g., EMA PRAC/RAPPS/CHMP consolidated LoQ).