Comments Sought on Electronic Drug Quality Data Submissions

FDA is encouraging the pharmaceutical industry to comment on its project to identify and prioritize pharmaceutical quality (PQ) and chemistry and manufacturing and controls (CMC) information that would benefit from a structured electronic submission approach. “Standardizing the format of structured data submission standardized format should increase the efficiency of FDA’s review of PQ/CMC data contained in the Module 3 of eCTD [electronic common technical document] submissions across several application types.

FDA has released a draft document, “Pharmaceutical Quality/Chemistry Manufacturing and Controls Data Exchange” that focuses on PQ/CMC structured data elements in the new health care data exchange standard from Health Level 7 (HL7), called Fast Health Interoperability Resources (FHIR). The agency says it is seeking feedback and comments on how the PQ/CMC data elements are represented in HL7 FHIR. Comments are being accepted through 5/17, 2022.

Learn more about FDA’s efforts to establish electronic standards for submitting PQ/CMC data on its newly launched Web page.