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FDA is requesting comment on draft document “Pharmaceutical Quality/Chemistry Manufacturing and Controls Data Exchange.”
FDA has released a draft document, Pharmaceutical Quality/Chemistry Manufacturing and Controls Data Exchange,” and is requesting comment for the electronic submission of PQ/CMC data. FDA released the draft document on March 18, 2022 and is requesting comments and feedback by May 17, 2022.
According to FDA, “this document provides draft design of Health Level 7 (HL7) Fast Health Interoperability Resources (FHIR) profiles that contain the data elements and terminologies associated with PQ/CMC subject areas and scoped to some of what is currently submitted in Module 3 of the electronic Common Technical Document (eCTD) submission.”
FDA is currently seeking feedback and comments on how the PQ/CMC data elements are represented in HL7 FHIR. The document is part of an effort intended to support future electronic acquisition and use of submitted information. The project aims to identify PQ/CMC information that would benefit from a structured submission approach. FDA has worked with the members of various HL7 workgroups, including the Biomedical Research and Regulation (BR&R) Workgroup, to develop the document.
This structured and standardized information is intended to be submitted in the Module 3 of the Common Technical Document as defined by the International Council for Harmonisation’s (ICH) M4 Common Technical Document (CTD). The document is not intended to be comprehensive in covering all eCTD product quality information.