Draft Pharmaceutical Quality/Chemistry Manufacturing and Controls Data Elements and Terminologies; Establishment of a Public Docket; Request for Comments

Issuing agencies

Abstract

The Food and Drug Administration (FDA or Agency) is requesting comment on the draft Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Elements and Terminologies for the electronic submission of PQ/CMC data. Building on the Agency's previous Federal Register notices published on July 11, 2017, and March 18, 2022, requesting comments on PQ/CMC data elements and controlled terminology, the Agency is continuing to seek comment on the accuracy, suitability, and appropriateness of revised and/or new data elements and terminologies for submission of PQ/CMC data. In addition, the progress toward the establishment of standardized pharmaceutical data elements and terminologies will require further interactions between the Agency and interested parties and various stakeholders, including industry. Accordingly, FDA is planning to request comment on additional PQ/CMC data elements and terminologies over time. FDA is establishing an open docket to facilitate efficient receipt of comments and public posting of updated draft documents on PQ/CMC data elements and terminologies.