The FDA invites comments on the draft “Pharmaceutical Quality/Chemistry Manufacturing and Controls Data Exchange” document.
The FDA released a draft document, Data exchange on manufacturing and pharmaceutical/chemical quality controlsand asks for comments for electronic submission of PQ/CMC data. The FDA released the draft document on March 18, 2022 and is seeking feedback and feedback by May 17, 2022.
According to the FDA, “This document provides a draft design of Health Level 7 (HL7) Rapid Health Interoperability Resource Profiles (FHIRs) that contain the data elements and terminologies associated with the PQ/CMC domains and extend to some of what is currently submitted in Module 3 of the electronic Common Technical Document (eCTD) submission.
The FDA is currently seeking input and feedback on how PQ/CMC data elements are represented in HL7 FHIR. The document is part of an effort 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. The FDA worked with members of various HL7 task forces, including the Biomedical Research and Regulation (BR&R) Task Force, to develop the document.
This structured and standardized information is intended to be submitted in Module 3 of the Common Technical Document as defined by the Common Technical Document (CTD) M4 of the International Council for Harmonization (ICH). The document is not intended to be exhaustive in covering all information on the quality of eCTD products.