20-22 June 2022
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:
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!