FDA publishes updated PQ/CMC Document for Comments

Recommendation

17/18 September 2024

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In March, the U.S. FDA published the draft of the "Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange" document for comments.

This document is part of a project, which has been in place since 2017 and includes the standardisation and structuring of submitted data from the PQ/CMC area in Module 3 of the electronic Common Technical Document (eCTD) . The following points are the central cornerstones of this project:

• The development of standards for the structured presentation of PQ/CMC data. 
• The development of a standard exchange system to submit the structured PQ/CMC data to the U.S. FDA.

Already in 2017, the U.S. FDA had published the first draft of the document and convened a public meeting regarding the project in 2018. The summaries of this are also available on the U.S. FDA website.

Here you can find the draft version of the "Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange" for the electronic submission of PQ/CMC data. The draft is available for comment until mid-May!