PQ/CMC Federal Register Notices
FDA has released several FRNs over the past few years covering the PQ/CMC project. As new sections of Module 3 eCTD (Electronic Common Technical Document) are structured and standardized, FDA publishes these through FRNs to solicit industry comments and feedback. The feedback is incorporated into the data elements and the supporting terminology, as relevant.
NOTE: These documents for comment are not to be construed in any way as FDA guidance or changes to FDA guidance. They are informational and for comment only.
New process for updates to PQ/CMC Data Elements and Terminologies for public comment:
Starting in 2023, FDA will be using a NEW process to publish the additions to and/or modifications of data elements and terminology and solicit public comment.
On May 1, 2023, FDA published a federal register notice announcing the establishment of an open docket on matters related to PQ/CMC Data Elements and Controlled Terminologies. Coinciding with publication of this notice, a new process for release of relevant information for public comment began where previous information published in March 2022 forms the first “chapter” of a growing set of draft data elements and terminology for PQ/CMC. Each update, adding and/or revising content for public comment, will be available at this webpage designated as a new “Chapter”. Here we will note if a new Chapter is available for public comment.
FDA will not be seeking public comment for earlier chapters since they already received public comment. However, since the content of new Chapters will be related to previous content, review of such content - solely as a reference - is highly recommended.
FDA will aim to provide a new Chapter of the PQ/CMC Data Elements and Terminologies periodically. FDA is targeting posting updates to this content to FDA’s PQ/CMC webpage by the end of the calendar months of March, June, September, and December of each year. This update may consist of a note that there is no new content for review in this period, or, alternatively, that there is new content to be reviewed for comment, along with a link to the relevant documentation, background, and instructions on submitting comments.
List of Chapters for PQ/CMC Data Elements and Terminologies – Current as of May 2023
- Chapters 1 and 2: Foundational Data Standards and Terminology for PQ/CMC (content originally released as part of the March 2022 FRN); Enhancements to support solid oral dosage form component and composition: multi-layer tablets and capsules (New); Support for drug product manufacturing of solid oral dosage forms (New). (May, 2023) Click here to download the document
Visit this section for future updates
Previous FRNs and Meeting History
2022 PQ/CMC FRN—FDA released a Federal Register Notice in 2022 [https://www.regulations.gov/document/FDA-2022-N-0297-0001] that provides the updated PQ/CMC Phase 1 Data elements and controlled terminology as well as Draft mappings [Data Elements & Terminologies Document] to Health Level 7 (HL7) Fast Health Interoperable Resources (FHIR). The focus of this second FRN is to seek industry input on the FHIR mappings.
2018 PQ/CMC Public Meeting—The Agency then held a public meeting in 2018, in support of the 2017 FRN. The presentations and recordings from this public meeting can be accessed from the links below.
- 2018 PQ/CMC Public Meeting Recordings:
2017 PQ/CMC FRN—In 2017, the FDA published a PQ/CMC Data Elements and Controlled Terminology document as part of FRN [https://www.federalregister.gov/a/2017-14456]. That document proposed structured data standards for a set of eCTD Module 3 content. There was a large volume of comments received from the industry in response to the FRN with overall support for structuring Module 3 content and detail comments on the data elements and controlled terminology. The comments and feedback were incorporated into the structured data elements and controlled terminology.
- For additional information/support from PQ/CMC Team, please contact PQ-CMC@fda.hhs.gov.