Draft Standardization of Pharmaceutical Quality/Chemistry Manufacturing and Control Data Elements and Terminologies; Request for Comments

The Food and Drug Administration (FDA or Agency) is requesting comment on the draft standardized Pharmaceutical Quality/Chemistry Manufacturing and Control (PQ/CMC) data elements and terminologies for the electronic submission of PQ/CMC data. The establishment of standardized pharmaceutical quality data elements and terminologies will provide opportunities for FDA and industry to transform PQ/CMC submission data into a readily useable electronic format. As a result, these established data elements and terminologies will improve the efficiency and quality of the drug review process. The Agency is seeking comment on the accuracy, suitability, and appropriateness of these data elements and terminologies for submission of PQ/CMC data. FDA is considering implementing PQ/CMC requirements as a Health Level 7 (HL7) Structured Product Labeling (SPL) document. The proposed data elements and terminologies can be obtained on https:// www.regulations.gov in Docket No. FDA-2017-N-2166.