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# PQ/CMC Information Electronic Submission Project
- URL: https://www.fdaweb.com/pq-cmc-information-electronic-submission-project/
- Published: 2022-03-31T12:00:00.000Z
- Updated: 2026-09-14T17:38:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151495

FDA says it has been working on a project to identify and prioritize pharmaceutical quality/chemistry, manufacturing, and controls (PQ/CMC) information that would benefit from a structured submission approach. “This structured and standardized information is intended to be submitted in Module 3 of the Common Technical Document as defined by the International Council for Harmonization’s M4 Common Technical Document,” an agency [notice](https://www.fda.gov/industry/fda-data-standards-advisory-board/pharmaceutical-qualitychemistry-manufacturing-controls-pqcmc?ref=fdaweb.com) says.

Specific objectives of the PQ/CMC project are: 

- develop structured data standards for PQ/CMC, and
- develop a data exchange standard for submitting the structured PQ/CMC data to FDA.

The notice reviews activities that have been undertaken as part of the project to date.