May 1 -- The Food and Drug Administration (FDA or Agency) is requesting comment on the draft Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Elements and Terminologies for the electronic submission of PQ/CMC data. Building on the Agency's previous Federal Register notices published on July 11, 2017, and March 18, 2022, requesting comments on PQ/CMC data elements and controlled terminology, the Agency is continuing to seek comment on the accuracy, suitability, and appropriateness of revised and/or new data elements and terminologies for submission of PQ/CMC data. In addition, the progress toward the establishment of standardized pharmaceutical data elements and terminologies will require further interactions between the Agency and interested parties and various stakeholders, including industry. Accordingly, FDA is planning to request comment on additional PQ/CMC data elements and terminologies over time. FDA is establishing an open docket to facilitate efficient receipt of comments and public posting of updated draft documents on PQ/CMC data elements and terminologies.
Comments may be submitted to this docket at any time.
PQ/CMC is a term used to describe manufacturing and testing data of pharmaceutical products. PQ/CMC encompasses topics such as drug stability, quality specification, batch formula, and batch analysis, which are important aspects of drug development and manufacturing. PQ/CMC plays an integral part in the regulatory review process and life-cycle management of pharmaceutical products. The development of a structured format for PQ/CMC data will enable consistency in the content and format of PQ/CMC data submitted, thus providing a harmonized language for submission content, allowing reviewers to query the data, and, in general, contributing to a more efficient and effective regulatory decision-making process by creating a standardized data dictionary.
The impetus for this standardization effort was the provisions from the 2012 Food and Drug Administration Safety and Innovation Act (Pub. L. 112–144), which authorized the Agency to require certain submissions to be submitted in a specified electronic format. PQ/CMC standardization supports FDA's regulatory needs in receiving structured and standardized pharmaceutical quality data and includes two objectives: (1) to standardize the pharmaceutical quality data that is currently received by FDA in electronic common technical document (eCTD) Module 3 (and relevant sections of Module 2) from the sponsoring organizations, and (2) to use these structured elements and develop a Health Level 7 Fast Health Interoperability Resources data exchange solution.
On July 11, 2017, FDA published a Federal Register notice requesting comment on a draft PQ/CMC Data Elements and Controlled Terminology document (82 FR 32003). That document proposed structured data standards for a set of eCTD Module 3 content. Based on a range of public feedback, FDA published a Federal Register notice on March 18, 2022 (87 FR 15435), requesting comment on a significantly revised and expanded set of data elements and terminologies, including additional subject areas of Module 3. The information released for public comment is not intended to be comprehensive in covering all eCTD product quality information, only those concepts that were considered amenable to structuring and would bring value to the quality review process. This information should not be viewed as guidance, technical specification, or an implementation guide, as it is meant solely for comment.
Through this notice, the Agency is continuing to seek comment on the accuracy, suitability, and appropriateness of revised and/or new data elements and terminologies for submission of PQ/CMC data. The Agency intends to issue guidance on the standardization of PQ/CMC data elements and terminologies for electronic submissions. . . .
Pharmaceutical Quality - Chemistry, Manufacturing & Controls (PQ/CMC)
https://www.fda.gov/industry/fda-data-standards-advisory-board/pharmaceutical-quality-chemistry-manufacturing-controls-pqcmc
FRN:
https://www.federalregister.gov/d/2023-09173