This audiocast highlights ongoing updates and developments in global regulatory chemistry, manufacturing, and controls (CMC) guidelines. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is developing the Q12 guideline to establish a framework for managing post-approval CMC changes for pharmaceutical products. The US Food and Drug Administration (FDA) is implementing its Quality Metrics Program, aimed at assessing the quality and consistency of pharmaceutical manufacturing processes. Proposed CMC regulatory guidance includes ICH Q13, which guides the use of continuous manufacturing, the EU's Medical Devices Regulation and In Vitro Diagnostic Devices Regulation, the USP's General Chapter (1083), and the FDA's draft guidance on comparability for biotechnology products. The FDA is also working on a project to establish electronic standards for submitting PQ/CMC data, which is intended to increase the efficiency of FDA's review of PQ/CMC data contained in Module 3 of eCTD submissions for various drug applications
