By Katie Duncan, Jon O'Connell
Published in: PHARMACEUTICAL ONLINE
Published on: September 28, 2026
ICH M4Q(R1) — the quality module of the common technical document — was written for a pre-digital era of regulatory CMC review.
Today's submissions are vastly more complicated, and they're expected to support much faster regulatory assessments. To catch up with regulatory expectations and greater data demands, the International Council for Harmonisation (ICH) set out to overhaul M4Q(R1) and develop the M16 Structured Product Quality Submission, a counterpart standard, to begin closing the gap.
To help us understand the changes to M4Q and how M16 enables structured submissions, Katie Duncan, a CMC policy and advocacy director at GSK and former FDA quality assessor, offered to answer some of our questions.
