New CMC Submission Approach Needed to Foster Transparency and Continuous Improvement, PhRMA Team Says; Embedding Control Strategy as Regulatory Commitment in QOS Proposed

A working group of prominent CMC experts across the member companies of the Pharmaceutical Research and Manufacturers of America (PhRMA) has formulated a proposal for a more performance and risk-based regulatory approach to CMC submissions that would better accommodate post-approval manufacturing and control improvements.

The proposal is emerging from an intensive review by a PhRMA Limited Duration Key Issues Team (LDKIT) focused on the problems in the current CMC review paradigm that have prevented industry’s quality by design (QbD) efforts from achieving the promise of regulatory flexibility throughout the product life-cycle.

Pharma’s LDKITs are set up under its Technical Development and Operations Committee (TDOC) to explore particular front-burner regulatory issues and develop a consensus proposal for addressing them.

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