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  5. PQ/CMC Federal Register Notices
  1. Pharmaceutical Quality - Chemistry, Manufacturing & Controls | PQ/CMC

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 September 2023

  1. 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) Download the document

Quarterly Updates

  • September 2023: There is no new content for this period
  • December 2023: There is no new content for this period
  • March 2024: There is no new content for this period
  • June 2024: There is no new content for this period
  • September 2024: We are requesting comment on a draft document regarding controlled terminology/vocabulary specifically focused on a set of coded quality attribute data elements and their categorization for therapeutic protein products. Since the content of this chapter is part of the early thinking of CDER’s Office of Pharmaceutical Quality (OPQ) which may ultimately be incorporated for use in development of Draft Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Elements and Terminology, we are presenting this as “Informational Chapter A”. The main Chapters of the Data Elements and Terminology living document represent information for comment on the comprehensive content development for PQ/CMC.  Informational Chapters will be used to represent earlier development for which an office or center would like input from the public.
    • Download this document for comment.
    • The open docket for public comment is here.
    • For clarity, please reference “Informational Chapter A” in your comments.
    • While the Open Docket technically does not close, for efficiency of reviewing comments, we are requesting a typical ~2 month period for submission of comments on this document by Friday December 5th, 2024.  As this is an open docket, we will still review comments after this period, but we are hoping to keep the work of assessing the comments contained to a reasonable time period.  We thank you for this consideration.

Previous FRNs and Meeting History

2022 PQ/CMC FRN

FDA released a Federal Register Notice in 2022 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.

2017 PQ/CMC FRN

In 2017, the FDA published a PQ/CMC Data Elements and Controlled Terminology document as part of FRN. 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.

Stay Connected

For additional information/support from PQ/CMC Team, please contact PQ-CMC@fda.hhs.gov.

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