USFDA Guidance on “Pharm. Quality/CMC Data Exchange" and Drug Products containing Nanoparticles
Draft PQ/CMC Data Exchange for Electronic Submission of PQ/CMC Data
On April 22 2022, USFDA, FDA has released the draft document, “Pharmaceutical Quality/Chemistry Manufacturing and Controls Data Exchange,” which is focused on the representation of those published PQ/CMC structured data elements in the new health care data exchange standard from Health Level 7 (HL7), called Fast Health Interoperability Resources (FHIR).
To support the future electronic acquisition and use of submitted information, FDA has undertaken a project to identify and prioritize pharmaceutical quality (PQ) and chemistry and manufacturing and controls (CMC) information that would benefit from a structured 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 submissions across several application types.
FDA is currently seeking feedback and comments on how the PQ/CMC data elements are represented in HL7 FHIR.

Guidance on Drug Products, Including Biological Products, that Contain Nanomaterials